In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study drugs involved in this study are: * Abemaciclib (CDK4 and CDK6 inhibitor) * Tamoxifen (Selective estrogen receptor modulator) * Anastrozole/Letrozole (Non-steroidal aromatase inhibitors) * Exemestane (steroidal aromatase inhibitor) * LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)
This research study is a prospective, single-arm, open label, phase 2 study designed to evaluate if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. This research study involves adjuvant abemaciclib plus endocrine (anti-hormone) therapy that works to target breast cancer. Adjuvant therapy is treatment given after surgery, chemotherapy, and/or radiation therapy. The U.S. Food and Drug Administration (FDA) has approved abemaciclib as a treatment option for early-stage high-risk hormone receptor breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer. The research study procedures include screening for eligibility, study treatment including laboratory evaluations and questionnaires, blood tests, tumor biopsies, and stool collections. Participation in this research study is expected to last for at least 2 years and up to 5 years. It is expected that about 90 people will take part in this research study. Eli Lilly and Company is supporting this study by providing funding for the study and supplying the study drug, abemaciclib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
CDK4 and CDK6 inhibitor, tablet taken orally
Selective estrogen receptor modulator, taken orally per institutional standard of care
Non-steroidal aromatase inhibitor, taken orally per institutional standard of care
Non-steroidal aromatase inhibitor, taken orally per institutional standard of care
Steroidal aromatase inhibitor, taken orally per institutional standard of care
Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Stamford Hospital
Stamford, Connecticut, United States
Eastern Maine Medical Center (Northern Light)
Brewer, Maine, United States
New England Cancer Specialists
Scarborough, Maine, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute at Steward St. Elizabeth's
Brighton, Massachusetts, United States
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, United States
Dana-Farber Cancer Institute at Merrimack Valley
Methuen, Massachusetts, United States
Dana-Farber Cancer Institute at Milford
Milford, Massachusetts, United States
...and 2 more locations
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 3 Months (12 Weeks)
The composite endpoint is the number and proportion of participants with abemaciclib discontinuation for any reason and/or abemaciclib dose reductions and/or the inability of study participants to reach the target dose of abemaciclib (full dose 150 mg BID) at 3 months (12 weeks).
Time frame: 3 months (12 weeks)
Number of Participants Unable to Reach Full Dose of Abemaciclib at 3 Months (12 Weeks)
Number of participants unable to reach the full dose (150 mg BID) of abemaciclib at 3 months (12 weeks)
Time frame: 3 months (12 weeks)
Number of Participants Who Discontinued Abemaciclib Treatment for Any Reason at 12 Weeks
Number of participants who discontinued abemaciclib treatment for any reason 3 months (12 weeks)
Time frame: 3 months (12 weeks)
Number of Participants With Abemaciclib Dose Reductions at 12 Weeks
Number of participants with abemaciclib dose reductions at 3 months (12 weeks)
Time frame: 3 months (12 weeks)
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Weeks
Among all patients who received at least one dose of Abemaciclib, summarize the maximum treatment-emergent diarrhea adverse event reported per subject (across any dose level received) between the start of treatment and up to 24 weeks. Adverse events (AEs) are graded in a clinical setting utilizing CTCAE v5.0 criteria; AEs of grade 2 to 5 are systematically reported, while grade 1 AEs are not systematically reported, so subjects with no reported AEs (grade 0) and subjects with a maximum grade 1 AE are combined into a single category. AEs are considered treatment-emergent if they start at or after the first dose of Abemaciclib. Grade 0 - no toxicity reported Grade 1 - mild Grade 2 - moderate Grade 3 - severe Grade 4 - life-threatening Grade 5 - fatal (no cases of grade 5 diarrhea to report)
Time frame: Up to 24 weeks
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Adverse Events by 24 Weeks
Among all patients who received at least one dose of Abemaciclib, summarize the maximum treatment-emergent adverse event (of any kind) reported per subject (across any dose level received) between the start of treatment and up to 24 weeks. Adverse events (AEs) are graded in a clinical setting utilizing CTCAE v5.0 criteria; AEs of grade 2 to 5 are systematically reported, while grade 1 AEs are not systematically reported, so subjects with no reported AEs (grade 0) and subjects with a maximum grade 1 AE are combined into a single category. AEs are considered treatment-emergent if they start at or after the first dose of Abemaciclib. Grade 0 - no toxicity reported Grade 1 - mild Grade 2 - moderate Grade 3 - severe Grade 4 - life-threatening Grade 5 - fatal (no cases of grade 5 toxicities)
Time frame: Up to 24 weeks
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 24 Weeks
The composite endpoint at 24 weeks is the number and proportion of participants with abemaciclib (abema) treatment discontinuations and/or abemaciclib dose reductions and/or participant inability to reach the target dose (full dose 150 mg BID) of abemaciclib at 24 weeks.
Time frame: Up to 24 weeks
Number of Participants Unable to Reach the Full Dose by 24 Weeks
Number of participants unable to reach the full dose will be reported as the rate of participants who have never reached the full dose of abemaciclib at 150mg BID by 24 weeks.
Time frame: Up to 24 weeks
Number of Participants Who Discontinued Abemaciclib Treatment for to Any Reason at 24 Weeks
Number of Participants who Discontinued Abemaciclib Treatment for to Any Reason at 24 Weeks (6 months)
Time frame: Up to 24 weeks
Number of Participants With Abemaciclib Dose Reductions at 24 Weeks
Number of Participants with Abemaciclib Dose Reductions at 24 Weeks (6 months)
Time frame: Up to 24 weeks
Number of Participants Unable to Maintain the Full Dose of Abemaciclib by 24 Weeks
Number of participants who reached the full dose of abemaciclib (150mg BID) but then had a dose reduction by 24 weeks
Time frame: Up to 24 weeks
Composite Endpoint: Number of Participants With Abemaciclib Discontinuation for Any Reason, Abemaciclib Dose Reductions, or the Inability of Study Participants to Reach the Target Dose of Abemaciclib (Full Dose 150 mg BID) at 24 Months
The composite endpoint is the number and proportion of participants with abemaciclib discontinuation for any reason and/or abemaciclib dose reductions and/or the inability of study participants to reach the target dose of abemaciclib (full dose 150 mg BID) at 24 months (at completion of adjuvant abemaciclib therapy for all subjects).
Time frame: Up to 24 months
Number of Participants Unable to Reach the Full Dose by 24 Months
Number of participants who have never reached the full dose of abemaciclib at 150mg BID by 24 months.
Time frame: Up to 24 months
Number of Participants Who Discontinued Abemaciclib Treatment Due to Any Reason Prior to 24 Months
Number of Participants who Discontinued Abemaciclib Treatment Due to Any Reason prior to 24 Months (at completion of adjuvant abemaciclib therapy for all subjects).
Time frame: Up to 24 months
Number of Participants With Abemaciclib Dose Reductions at 24 Months
Number of Participants with Abemaciclib Dose Reductions at 24 months (at completion of adjuvant abemaciclib therapy for all subjects).
Time frame: Up to 24 months
Number of Participants Unable to Maintain the Full Dose of Abemaciclib by 24 Months
Number of participants who reached the full dose of abemaciclib (150mg BID) but then had a dose reduction by 24 months
Time frame: Up to 24 months
Number of Participants Experiencing CTCAE v5.0 Treatment-emergent Grade 2-4 Diarrhea by 24 Months
Among all patients who received at least one dose of Abemaciclib, summarize the maximum treatment-emergent diarrhea adverse event reported per subject (across any dose level received) between the start of treatment and up to 24 months. Adverse events (AEs) are graded in a clinical setting utilizing CTCAE v5.0 criteria; AEs of grade 2 to 5 are systematically reported, while grade 1 AEs are not systematically reported, so subjects with no reported AEs (grade 0) and subjects with a maximum grade 1 AE are combined into a single category. AEs are considered treatment-emergent if they start at or after the first dose of Abemaciclib. Grade 0 - no toxicity reported Grade 1 - mild Grade 2 - moderate Grade 3 - severe Grade 4 - life-threatening Grade 5 - fatal
Time frame: Up to 24 months
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