A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

Recruiting Phase 2 Phase 3 Interventional Study
HER2-positive Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd. · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Voluntarily signed informed consent and followed the program requirements; 2. Females ≥18 and ≤75 years of age at the time of signing the informed consent; 3. Expected survival time ≥6 months; 4. Patients with HER2-positive invasive breast cancer confirmed by histologic exami…
Contacts

Sa Xiao, PHD

15013238943

xiaosa@baili-pharm.com

CONTACT