Actively Recruiting
A Randomized Controlled Phase II/III 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
N/A
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
Researchers are evaluating BL-M07D1 with or without Pertuzumab in the treatment of HER2-positive breast cancer before surgery. This phase II and III randomized, open, multicenter trial aims to assess the effectiveness and safety of these treatments compared to standard therapy with Taxane, Trastuzumab, and Pertuzumab. The study focuses on patients with stage II-III invasive HER2-positive breast cancer who have not previously received antitumor therapy for breast cancer. Participants receive BL-M07D1 with or without Pertuzumab through intravenous infusion in cycles lasting 3 weeks. Those who respond well may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons lead to stopping. The study includes a single-arm phase II followed by a randomized controlled phase III to compare treatments. During the trial, participants will undergo evaluations including surgery after neoadjuvant therapy, physical health assessments, and laboratory tests to monitor organ function and side effects. Researchers will measure outcomes such as the rate of complete pathological response, event-free survival, disease-free survival, overall survival, and treatment-related adverse events over approximately 48 months. The study lasts through treatment and follow-up to assess long-term effects and safety.
CONDITIONS
Brief 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
- Signed informed consent and willing to follow study requirements
- Expected survival time of 6 months or more
- Confirmed HER2-positive invasive breast cancer by biopsy
- Known hormone receptor status
- Clinical stage II or III breast cancer before treatment
- No prior antitumor therapy for breast cancer
- Willing to undergo mastectomy or breast-conserving surgery after treatment
- Surgery planned 2 to 6 weeks after last dose of neoadjuvant therapy
- ECOG performance status 0 or 1
- Adequate organ function without recent blood transfusions or colony-stimulating factors
- Negative pregnancy test for premenopausal women and use of effective contraception during and 7 months after treatment
- Not lactating
You will not qualify if you...
- Stage IV metastatic breast cancer
- Bilateral breast cancer
- Prior history of breast cancer except lobular carcinoma in situ
- Other primary cancers diagnosed within 5 years
- Severe cardiovascular or cerebrovascular disease in past 6 months
- Certain heart rhythm disorders
- Poorly controlled high blood pressure
- Severe lung disease impairing function
- History or current interstitial lung disease or pneumonitis
- HIV antibody positive or active hepatitis B/C infection or cirrhosis
- Severe infection within 4 weeks before treatment
- Use of high-dose corticosteroids or immunosuppressive therapy within 2 weeks before treatment
- Known allergy to study drugs or related antibodies
- Unsuitable to receive study drugs such as paclitaxel, patulizumab, trastuzumab
- History of stem cell or organ transplantation
- Severe neurological or psychiatric disorders
- Significant bleeding or bleeding tendency within 4 weeks
- Intestinal diseases like obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Recent live vaccine use or planned within 28 days
- Other serious health issues or poor compliance affecting study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive BL-M07D1 with or without Pertuzumab by intravenous infusion in 3-week cycles. Treatment may continue for additional cycles depending on clinical benefit, until disease progression or intolerable toxicity.
1 visit per cycle (in-person)
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
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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