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

Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Anyang Cancer Hospital
NOT_YET_RECRUITING
Anyang
The First Affiliated Hospital of Bengbu Medical University
NOT_YET_RECRUITING
Bengbu
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Cancer Hospital
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Guangdong Maternal and Child Health Center
NOT_YET_RECRUITING
Guangzhou
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
NOT_YET_RECRUITING
Guangzhou
Hainan General Hospital
NOT_YET_RECRUITING
Haikou
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Anhui Provincial Cancer Hospital
NOT_YET_RECRUITING
Hefei
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
NOT_YET_RECRUITING
Hefei
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
Liuzhou People's Hospital
NOT_YET_RECRUITING
Liuzhou
The First Affiliated Hospital of Henan University of science and technology
NOT_YET_RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
NOT_YET_RECRUITING
Shenzhen
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
Shanxi Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Tianjin Cancer Hospital
NOT_YET_RECRUITING
Tianjin
Shaanxi Provincial People's Hospital
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Xingtai People's Hospital
NOT_YET_RECRUITING
Xingtai
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2028-12
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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