RecruitingPhase 2Phase 3NCT06891833

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

A Randomized Controlled Phase II/III Clinical Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

120 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer

Summary

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).

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new treatment combination using a drug called BL-M07D1 (with or without pertuzumab) against the current standard treatment (taxane chemotherapy plus trastuzumab and pertuzumab) given before surgery (called neoadjuvant therapy) in women with HER2-positive breast cancer. **You may be eligible if...** - You are a woman aged 18–75 - You have HER2-positive invasive breast cancer confirmed by biopsy - Your cancer is clinical stage II or III - You have not yet had any treatment for your breast cancer - You are willing to have surgery (mastectomy or breast-conserving surgery) after the pre-surgery treatment **You may NOT be eligible if...** - You have already received treatment for your breast cancer - You have serious organ problems or a performance status that would make treatment unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBL-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGPertuzumab

Administration by intravenous infusion for a cycle of 3 weeks.

Locations(30)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangdong Maternal and Child Health Center

Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Hainan General Hospital

Haikou, Hainan, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Xingtai People's Hospital

Xingtai, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Anyang Cancer Hospital

Anyang, Henan, China

The First Affiliated Hospital of Henan University of science and technology

Luoyang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06891833

Related Trials

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

NCT0710238126 locations

ATEMPT 2.0: Adjuvant T-DM1 vs TH

NCT0489310953 locations

HER2 Vaccine for Locally Advanced Breast Cancer

NCT069494101 location

Tumor-microenvironment Spatial Interaction to Identify Markers of Resistance to Therapy in HER2+ Breast Cancer Patients

NCT065183821 location

A Phase 1/1b Study of IAM1363 in HER2 Cancers

NCT0625387148 locations