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

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).

Study Overview

• Status: Recruiting
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Drug: BL-M07D1; Drug: Pertuzumab

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sa Xiao, PHD; Phone Number: 15013238943; Email: xiaosa@baili-pharm.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Not yet recruiting
      • The First Affiliated Hospital of Bengbu Medical University
      • Contact: Xin Jin
    • Hefei, Anhui, China
      • Not yet recruiting
      • Anhui Provincial Cancer Hospital
      • Contact: Yueyin Pan
    • Hefei, Anhui, China
      • Not yet recruiting
      • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
      • Contact: Xiaopeng Ma
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Not yet recruiting
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Qiao Cheng
  • Fujian
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • Fujian Medical University Union Hospital
      • Contact: Chuan Wang
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Qiang Liu
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong Maternal and Child Health Center
      • Contact: Antai Zhang
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
      • Contact: Jidong Gao
  • Guangxi
    • Liuzhou, Guangxi, China
      • Not yet recruiting
      • Liuzhou People's Hospital
      • Contact: Junyang Mo
    • Nanning, Guangxi, China
      • Not yet recruiting
      • Guangxi Medical University Cancer Hospital
      • Contact: Huawei Yang
  • Hainan
    • Haikou, Hainan, China
      • Not yet recruiting
      • Hainan General Hospital
      • Contact: Ru Chen
  • Hebei
    • Shijiazhuang, Hebei, China
      • Not yet recruiting
      • The Fourth Hospital of Hebei Medical University
      • Contact: Yunjiang Liu
    • Xingtai, Hebei, China
      • Not yet recruiting
      • Xingtai People's Hospital
      • Contact: Xiangshun Kong
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Not yet recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Tong Liu
  • Henan
    • Anyang, Henan, China
      • Not yet recruiting
      • Anyang Cancer Hospital
      • Contact: Ya Wei
    • Luoyang, Henan, China
      • Not yet recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
      • Contact: Xinshuai Wang
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Provincial People's Hospital
      • Contact: Hui Liu
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • The Second Xiangya Hospital Of Central South University
      • Contact: Wenjun Yi
    • Changsha, Hunan, China
      • Not yet recruiting
      • Hunan Cancer Hospital
      • Contact: Xiaobo Hu
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Yingliang Li
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Not yet recruiting
      • The First Affiliated Hospital Of Xi'an Jiaotong University
      • Contact: Yu Ren
    • Xi'an, Shaanxi, China
      • Not yet recruiting
      • Shaanxi Provincial People's Hospital
      • Contact: Jianhui Li
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Shandong Cancer Hospital
      • Contact: Yongsheng Wang
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Zhimin Shao
  • Shanxi
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • Shanxi Bethune Hospital
      • Contact: Xiaojun Zhang
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • Shanxi Cancer Hospital
      • Contact: Guohui Han
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • Sichuan Cancer Hospital
      • Contact: Junjie Li
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Not yet recruiting
      • Tianjin Cancer Hospital
      • Contact: Jin Zhang
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Cancer Hospital
      • Contact: Yang Yu
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Peifen Fu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 examination;
5. Clear hormone receptor (HR) status;
6. Clear clinical stage II-III based on American Joint Committee on Cancer (AJCC) staging 8th edition prior to neoadjuvant therapy;
7. Primary subjects without antitumor therapy for breast cancer;
8. Subjects consenting to mastectomy or breast-conserving surgery at the end of neoadjuvant therapy;
9. Radical surgery to the last dose of neoadjuvant therapy at least 2 weeks apart and up to 6 weeks apart;
10. Physical status score ECOG 0 or 1;
11. 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;
12. 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.

Exclusion Criteria:

1. Diagnosis of stage IV metastatic breast cancer;
2. Bilateral breast cancer;
3. Prior history of any breast cancer (unilateral or contralateral) other than lobular carcinoma in situ (LCIS);
4. Diagnosis of another primary malignancy within 5 years prior to first dose;
5. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;
6. Prolonged QT interval, complete left bundle branch block, degree III atrioventricular block, and frequent and uncontrollable arrhythmias;
7. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);
8. Complicated lung disease resulting in severely impaired lung function;
9. History of ILD / interstitial pneumonitis requiring steroid hormone therapy, current ILD / interstitial pneumonitis, or suspected of having such a disease, etc;
10. Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;
11. Severe infection within 4 weeks prior to first dose of study drug; active pulmonary inflammation present at screening;
12. 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;
13. Known hypersensitivity to the study therapeutic drug or any study drug excipients or other monoclonal antibodies;
14. Patients who are not suitable to receive the investigational drug (paclitaxel, patulizumab, trastuzumab);
15. Have a history of autologous or allogeneic stem cell transplantation or organ transplantation;
16. Suffering from severe neurological or psychiatric disorders;
17. Subjects with clinically significant bleeding or significant bleeding tendency within 4 weeks prior to signing the information;
18. Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;
19. Subjects who are scheduled to receive a live vaccine or who have received a live vaccine within 28 days prior to the first dose;
20. Presence of other serious physical, laboratory test abnormalities or poor compliance that may increase the risk of participation in the study or interfere with the study results, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study treatment; Participants 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.	Drug: BL-M07D1; Administration by intravenous infusion for a cycle of 3 weeks.; Drug: Pertuzumab; Administration by intravenous infusion for a cycle of 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response (pCR) rate	Pathological complete response (pCR) rate will be investigated.	Up to approximately 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival (EFS)	Event-free survival (EFS) is defined as the time between the day the subject is randomized and the first occurrence of any event.	Up to approximately 48 months
Invasive disease-free survival (IDFS)	Invasive disease-free survival (IDFS) is defined as the time interval from the date of radical surgery to the presence of ipsilateral or contralateral recurrence of invasive breast cancer, locoregional recurrence, distant recurrence, or death from any cause, whichever occurs first.	Up to approximately 48 months
Overall Survival (OS)	Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.	Up to approximately 48 months
Treatment Emergent Adverse Event (TEAE)	TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.	Up to approximately 48 months

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 27, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; pertuzumab
• Other Study ID Numbers: BL-M07D1-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No