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
1 other identifier
interventional
120
1 country
30
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2025
Typical duration for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2025
CompletedFirst Posted
Study publicly available on registry
March 24, 2025
CompletedStudy Start
First participant enrolled
June 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
October 2, 2025
September 1, 2025
3.5 years
March 18, 2025
September 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pathological complete response (pCR) rate
Pathological complete response (pCR) rate will be investigated.
Up to approximately 48 months
Secondary Outcomes (4)
Event-free survival (EFS)
Up to approximately 48 months
Invasive disease-free survival (IDFS)
Up to approximately 48 months
Overall Survival (OS)
Up to approximately 48 months
Treatment Emergent Adverse Event (TEAE)
Up to approximately 48 months
Study Arms (1)
Study treatment
EXPERIMENTALParticipants receive BL-M07D1 with or without Pertuzumab for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Interventions
Eligibility Criteria
You may qualify if:
- Voluntarily signed informed consent and followed the program requirements;
- Females ≥18 and ≤75 years of age at the time of signing the informed consent;
- Expected survival time ≥6 months;
- Patients with HER2-positive invasive breast cancer confirmed by histologic examination;
- Clear hormone receptor (HR) status;
- Clear clinical stage II-III based on American Joint Committee on Cancer (AJCC) staging 8th edition prior to neoadjuvant therapy;
- Primary subjects without antitumor therapy for breast cancer;
- Subjects consenting to mastectomy or breast-conserving surgery at the end of neoadjuvant therapy;
- Radical surgery to the last dose of neoadjuvant therapy at least 2 weeks apart and up to 6 weeks apart;
- Physical status score ECOG 0 or 1;
- Organ function levels must be met provided that blood transfusions are not permitted within 14 days prior to the first administration of study drug, colony-stimulating factors are not permitted, and so on;
- For premenopausal women of childbearing potential a pregnancy test must be performed within 7 days prior to initiation of treatment, serum pregnancy must be negative, and must be non-lactating; all enrolled patients should be using adequate and highly effective contraception throughout the treatment cycle and for 7 months after completion of treatment.
You may not qualify if:
- Diagnosis of stage IV metastatic breast cancer;
- Bilateral breast cancer;
- Prior history of any breast cancer (unilateral or contralateral) other than lobular carcinoma in situ (LCIS);
- Diagnosis of another primary malignancy within 5 years prior to first dose;
- History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
- Prolonged QT interval, complete left bundle branch block, degree III atrioventricular block, and frequent and uncontrollable arrhythmias;
- Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- Complicated lung disease resulting in severely impaired lung function;
- History of ILD / interstitial pneumonitis requiring steroid hormone therapy, current ILD / interstitial pneumonitis, or suspected of having such a disease, etc;
- Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;
- Severe infection within 4 weeks prior to first dose of study drug; active pulmonary inflammation present at screening;
- Ongoing treatment with \>10 mg/d prednisone systemic corticosteroid therapy or equivalent anti-inflammatory active drug or any form of immunosuppressive therapy within 2 weeks prior to the first dose;
- Known hypersensitivity to the study therapeutic drug or any study drug excipients or other monoclonal antibodies;
- Patients who are not suitable to receive the investigational drug (paclitaxel, patulizumab, trastuzumab);
- Have a history of autologous or allogeneic stem cell transplantation or organ transplantation;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Liuchow, 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
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2025
First Posted
March 24, 2025
Study Start
June 5, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
October 2, 2025
Record last verified: 2025-09