This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 with or without Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
Pathological complete response (pCR) rate
Pathological complete response (pCR) rate will be investigated.
Time frame: Up to approximately 48 months
Event-free survival (EFS)
Event-free survival (EFS) is defined as the time between the day the subject is randomized and the first occurrence of any event.
Time frame: Up to approximately 48 months
Invasive disease-free survival (IDFS)
Invasive disease-free survival (IDFS) is defined as the time interval from the date of radical surgery to the presence of ipsilateral or contralateral recurrence of invasive breast cancer, locoregional recurrence, distant recurrence, or death from any cause, whichever occurs first.
Time frame: Up to approximately 48 months
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Time frame: Up to approximately 48 months
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.
Time frame: Up to approximately 48 months
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NOT_YET_RECRUITINGThe First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
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NOT_YET_RECRUITING...and 20 more locations