Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

Percentage of Participants Achieving pCR as Per ICR in ITT Analysis Set With 95% CI

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Percentage of Participants Achieving pCR as Per Investigator in Evaluable Analysis Set as Per Investigator

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.

Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Percentage of Participants Achieving pCR as Per Investigator in ITT Analysis Set

pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Percentage of Participants Achieving pCR in Breast Only as Per Investigator in Evaluable Analysis Set as Per Investigator

pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.

Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Percentage of Participants Achieving pCR in Breast Only as Per Investigator in ITT Analysis Set

pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Percentage of Participants Achieving pCR in Breast Only as Per ICR in Evaluable Analysis Set as Per ICR

pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.

Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Percentage of Participants Achieving pCR in Breast Only as Per ICR in ITT Analysis Set

pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.

Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR

The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.

Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Percentage of Participants With RCB as Per ICR in ITT Analysis Set

The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.

Time frame: Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)

Probability of Being Event-Free at 3 Years in Evaluable Analysis Set

Event-Free Survival (EFS) is defined as the time from surgery date to first documentation of local or distant recurrence or death or initiation of antineoplastic therapy before documentation of first relapse. Participants discontinuing study before documentation of first relapse or death, but after surgery were censored observations for EFS. EFS at 3 years is defined as the probability of being event free at 3 years after surgery using Kaplan Meier methods.

Time frame: 3 years after surgery

Probability of Being Alive at 3 Years in Evaluable Analysis Set

Overall Survival (OS) is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.

Time frame: 3 years after first dose of talazoparib

Probability of Being Alive at 3 Years in ITT Analysis Set

OS is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.

Time frame: 3 years after first dose of talazoparib

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or worsened relative to pretreatment state. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE.

Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Number of Participants With Serious Adverse Events (SAEs)

An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.

Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Drug

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Number of Participants With TEAEs Leading to Temporary Discontinuation of Study Drug

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Number of Participants With TEAEs Leading to Dose Reduction of Study Drug

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Number of Participants With Laboratory Abnormalities

Laboratory parameters included hematology, serum chemistry, urinalysis and coagulation. Grades of laboratory abnormalities were defined according to NCI CTCAE version 4.03. Participants with laboratory test abnormalities meeting specified criteria (\>upper limit of normal \[ULN\] or \<lower limit of normal \[LLN\]) (without regards to baseline abnormality) are reported.

Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline

Hematology laboratory parameters included hematocrit, hemoglobin, mean corpuscular volume, red blood cells, platelets, white blood cells with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Grades of lab results were defined by NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. This outcome measure was based only on laboratory data. As Grade 4 anemia cannot be assessed based only on laboratory data, it was not applicable for analysis in this outcome measure.

Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline

Chemistry laboratory parameters included albumin, total protein, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, creatinine, non-fasting glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and lactate dehydrogenase. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 1 (Mild) = asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 (Moderate ) = minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4 = events with life-threatening consequences, urgent intervention indicated; Grade 5 = death related to AE.

Time frame: Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)

Trough Plasma Concentration (Ctrough) of Talazoparib in Cycles 2, 3 and 4 in PK Analysis Set

Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4

Within-Participant Average Ctrough of Talazoparib at Steady State in PK Analysis Set

Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.

Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4

Ctrough of Talazoparib in Cycles 2, 3 and 4 in Dose-Compliant PK Analysis Set

Time frame: Pre-dose on Day 1 of Cycles 2, 3, 4

Within-Participant Average Ctrough of Talazoparib at Steady State in Dose-Compliant PK Analysis Set

Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.

Time frame: Pre-dosing on Day 1 of Cycles 2, 3, 4

Number of Participants Who Achieved Definitive Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Per European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-30)

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes (PROs), consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease.

Time frame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Kaplan-Meier Estimate of Time to Definitive Deterioration in GHS/QoL Per EORTC QLQ-30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease.

Time frame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Probability of Not Achieving Definitive Deterioration in GHS/QoL Per EORTC QLQ-C30 at 3 and 6 Months

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent \<10 point decrease. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using the Kaplan Meier method were reported.

Time frame: 3 months and 6 months post-baseline

Number of Participants Who Achieved Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent \<10 point increase.

Time frame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Kaplan-Meier Estimate of Time to Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent \<10 point increase.

Time frame: Baseline to End of Treatment visit (assessed for maximum of 33 weeks)

Probability of Not Achieving Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 at 3 and 6 Months

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, with 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores (1=very poor to 7=excellent); other items have 4 possible scores (1=not at all to 4=very much). For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A linear transformation was applied to raw scores so that transformed scores lie between 0 to 100, with 0 being the best and 100 being the worst for this symptom scale. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as≥10 point increase from baseline without any subsequent \<10 point increase. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using Kaplan Meier method were reported.

Time frame: 3 months and 6 months post-baseline

Change From Baseline in Global QoL Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. Negative change from baseline indicates deterioration in GHS/QoL and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Physical Functioning Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the physical functioning scale, participants self-rated levels of difficulty in doing strenuous activities, taking a walk, how much they needed to stay in bed or a chair, or needed help with eating, dressing, bathing, using the toilet. Negative change from baseline indicates deterioration in physical functioning and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Role Functioning Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the role functioning scale, participants self-rated how much they were limited in doing work or daily activities, or in pursuing hobbies or other leisure time activities during the past week. Negative change from baseline values indicates deterioration in role functioning and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Emotional Functioning Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the emotional functioning scale, participants self-rated how much they felt tense, worried, irritable or depressed during the past week. Negative change from baseline values indicates deterioration in emotional functioning and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the cognitive functioning scale, participants self-rated the extent of difficulty in concentrating on things or remembering things during the past week. Negative change from baseline values indicates deterioration in cognitive functioning and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Social Functioning Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the social functioning scale, participants self-rated how much their physical condition or medical treatment interfered with their family life and social activities during the past week. Negative change from baseline values indicates deterioration in social functioning and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the fatigue symptoms scale, participants self-rated how much they had felt weak, tired or needed to rest during the past week. Negative change from baseline values indicates improvement of fatigue symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. Negative change from baseline values indicates improvement of nausea and vomiting symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Pain Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the pain symptoms scale, participants self-rated the extent of pain and how much the pain interfered with daily activities during the past week. Negative change from baseline values indicates improvement of pain symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the dyspnoea symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of dyspnoea symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the insomnia symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of insomnia symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the appetite loss symptoms scale, participants self-rated the extent of lack of appetite during the past week. Negative change from baseline values indicates improvement of appetite loss symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the constipation symptoms scale, participants self-rated the intensity of constipation during the past week. Negative change from baseline values indicates improvement of constipation symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the diarrhea symptoms scale, participants self-rated the intensity of diarrhea during the past week. Negative change from baseline values indicates improvement of diarrhea symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Financial Difficulties Per EORTC QLQ-C30

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the symptom scale of financial difficulties, participants self-rated how much their physical condition or medical treatment caused financial difficulties. Negative change from baseline values indicates improvement of financial difficulties and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23)

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of body image, participants self-rated how much they felt physically less attractive or less feminine, difficult to look at themselves naked, or dissatisfied with their body during the past week. Negative change from baseline indicates worsening of self-rated body image and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the sexual functioning scale, participants self-rated to what extent they were interested in sex and were sexually active (with or without intercourse) during the past 4 weeks. Negative change from baseline values indicates worsening of sexual functioning and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of sexual enjoyment, participants self-rated to what extent sex was enjoyable for them during the past 4 weeks. Negative change from baseline values indicates worsening of sexual enjoyment and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Future Perspective Per EORTC QLQ-BR23

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the functional scale of future perspective, participants self-rated how much they were worried about their health in the future. Negative change from baseline values indicates worsening of future perspective and positive change indicates improvement.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the systemic therapy side effects scale, participants self-rated the intensity of symptoms of dry mouth, unusual taste, pain and irritation of eyes, hair loss, feeling ill or unwell, hot flushes and headaches during the past week. Negative change from baseline= improvement of these side effects, positive change = deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the breast symptoms scale, participants self-rated how much they had pain or skin problems (e.g. itchy, dry, flaky) on or in the area of affected breast, and how much this area was swollen or oversensitive during the past week. Negative change from baseline indicates improvement of breast symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the arm symptoms scale, participants self-rated how much they had pain in the arm or shoulder, how much the arm or hand was swollen, and difficulty in raising the arm or moving it sideways. Negative change from baseline indicates improvement of arm symptoms and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the upset by hair loss scale, participants self-rated how upset they were due to loss of hair during the past week. Negative change from baseline values indicates improvement of upset by hair loss and positive change indicates deterioration.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Number of Participants With Deterioration in Nausea/Vomiting Symptoms

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Deterioration in nausea and vomiting symptoms was defined as a 10 point or more increase from baseline for that specific time point.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Number of Participants With Improvement in Nausea/Vomiting Symptoms

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Improvement in nausea and vomiting symptoms was defined as a 10 point or more decrease from baseline for that specific time point.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Number of Participants With No Change in Nausea/Vomiting Symptoms

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. No change in nausea/vomiting symptoms=having neither deterioration (≥10 point increase from baseline) nor improvement (≥10 point decrease from baseline) for the time point.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)

Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Missed expected menstrual period was assessed electronically using the PRO CTCAE questionnaire, a PRO measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This objective captures the concept of fertility preservation through PRO, since there is a possible fertility sparing effect of talazoparib versus chemotherapy.

Time frame: Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)