Actively Recruiting
A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-10-02
120
Participants Needed
30
Research Sites
182 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years at time of consent
- Voluntarily signed informed consent and agree to follow study requirements
- Expected survival time of at least 6 months
- Confirmed HER2-positive invasive breast cancer by histologic examination
- Clear hormone receptor status
- Clinical stage II-III breast cancer based on AJCC 8th edition prior to neoadjuvant therapy
- No prior antitumor therapy for breast cancer
- Consent to mastectomy or breast-conserving surgery after neoadjuvant therapy
- Surgery scheduled 2 to 6 weeks after last neoadjuvant therapy dose
- Physical status score ECOG 0 or 1
- Organ function adequate, with no blood transfusions within 14 days prior to first study drug dose
- Negative pregnancy test within 7 days prior to treatment for premenopausal women of childbearing potential
- Non-lactating and using effective contraception during treatment and for 7 months after completion
You will not qualify if you...
- Diagnosis of stage IV metastatic breast cancer
- Bilateral breast cancer
- Prior history of any breast cancer except lobular carcinoma in situ
- Other primary malignancy diagnosed within 5 years prior to first dose
- Severe cardiovascular or cerebrovascular disease within 6 months prior to screening
- Prolonged QT interval, complete left bundle branch block, degree III atrioventricular block, or frequent uncontrollable arrhythmias
- Poorly controlled hypertension (systolic >150 mmHg or diastolic >100 mmHg)
- Severe lung disease impairing lung function
- History or presence of ILD/interstitial pneumonitis requiring steroid therapy
- HIV antibody positive, active hepatitis B, cirrhosis, or hepatitis C infection
- Severe infection within 4 weeks prior to first dose; active pulmonary inflammation at screening
- Use of systemic corticosteroids >10 mg/d prednisone or immunosuppressive therapy within 2 weeks prior to first dose
- Known hypersensitivity to study drugs or monoclonal antibodies
- Unsuitability for investigational drugs (paclitaxel, patulizumab, trastuzumab)
- History of stem cell or organ transplantation
- Severe neurological or psychiatric disorders
- Significant bleeding or bleeding tendency within 4 weeks prior to consent
- Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Scheduled or recent live vaccine within 28 days prior to first dose
- Other serious physical or laboratory abnormalities or poor compliance increasing study risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Not Yet Recruiting
2
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Not Yet Recruiting
3
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Not Yet Recruiting
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
5
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
6
Guangdong Maternal and Child Health Center
Guangzhou, Guangdong, China
Not Yet Recruiting
7
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
8
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
Not Yet Recruiting
9
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Not Yet Recruiting
10
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Not Yet Recruiting
11
Hainan General Hospital
Haikou, Hainan, China
Not Yet Recruiting
12
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Not Yet Recruiting
13
Xingtai People's Hospital
Xingtai, Hebei, China
Not Yet Recruiting
14
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
15
Anyang Cancer Hospital
Anyang, Henan, China
Not Yet Recruiting
16
The First Affiliated Hospital of Henan University of science and technology
Luoyang, Henan, China
Not Yet Recruiting
17
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
18
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
19
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
20
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
21
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Not Yet Recruiting
22
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Not Yet Recruiting
23
Shandong Cancer Hospital
Jinan, Shandong, China
Not Yet Recruiting
24
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
25
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
26
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
27
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
28
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
29
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
30
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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