This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle
Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle
Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC)
Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Time frame: Up to approximately 37 months from first patient in
Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.
Time frame: Up to approximately 37 months from first patient in
PFS assessed by investigator
Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Time frame: Up to approximately 37 months from first patient in
Objective response rate (ORR) assessed by BIRC or investigators
ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BIRC or investigators based on RECIST 1.1 is presented.
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The first affiliated hospital of bengbu medical University
Bengbu, Anhui, China
RECRUITINGThe First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGFifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe Southwest Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Provincial Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGLanzhou University First Hospital
Lanzhou, Gansu, China
RECRUITINGThe First People's Hospital of Foshan
Foshan, Guangdong, China
RECRUITING...and 60 more locations
Time frame: Up to approximately 37 months from first patient in
Disease control rate (DCR) assessed by BIRC or investigators
DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by BIRC or investigators using RECIST v1.1
Time frame: Up to approximately 37 months from first patient in
Duration of response (DoR) assessed by BIRC or investigators
DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.
Time frame: Up to approximately 37 months from first patient in
Incidence and severity of Adverse Event (AE) according to CTCAE 5.0
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to 30 days after last treatment
Differences in the scores of health-related quality of life (HRQol) evaluated by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
Time frame: Up to 30 days after last treatment
Differences in the scores of health-related quality of life (HRQol) evaluated by EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR42)
Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale.
Time frame: Up to 30 days after last treatment