Clinical trial NCT06891833: A Study of BL-M07D1 + Pertuzumab With or Without Taxane Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
Official title: A Randomized Controlled Phase II/III Clinical Study of BL-M07D1 + Pertuzumab With or Without Taxane Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: HER2-positive Breast Cancer
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
First posted: 2025-03-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 + Pertuzumab in combination with or without taxane regimen 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 criteria: 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.

Primary outcomes:
measure: Pathological complete response (pCR) rate
timeFrame: Up to approximately 48 months
Secondary outcomes:
measure: Event-free survival (EFS)
timeFrame: Up to approximately 48 months
measure: Invasive disease-free survival (IDFS)
timeFrame: Up to approximately 48 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 48 months
measure: Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 48 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
state: Anhui
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Maternal and Child Health Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of science and technology
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: