Neoadjuvant BL-M07D1 (with or without pertuzumab) versus taxane + trastuzumab + pertuzumab 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 will try whether giving the experimental antibody BL-M07D1, with or without pertuzumab, before surgery improves outcomes for people with HER2-positive breast cancer compared with the standard taxane plus trastuzumab and pertuzumab regimen.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: patulizumab, trastuzumab, prednisone, Pertuzumab
• Locations: 30 sites (Bengbu, Anhui and 29 other locations)
• Trial ID: NCT06891833 on ClinicalTrials.gov

What this trial studies

This randomized, open-label, multicenter Phase II/III trial tests the experimental antibody BL-M07D1 given with or without pertuzumab as neoadjuvant treatment versus a standard regimen of taxane plus trastuzumab and pertuzumab in patients with stage II–III HER2-positive breast cancer. The study begins with a single-arm Phase II portion followed by a randomized Phase III comparison; treatments are given before planned surgery to measure pre-operative tumor response and safety. Eligible participants are chemotherapy‑naive adult women with confirmed HER2‑positive invasive disease and ECOG performance status 0–1 with adequate organ function. Sites for enrollment are located in Anhui province, China, and patients will undergo surgery after completing neoadjuvant therapy per protocol.

Who should consider this trial

Good fit: Adult women (18–75 years) with confirmed HER2-positive, stage II–III invasive breast cancer who have not received prior systemic therapy and who are fit for neoadjuvant treatment and surgery are the intended participants.

Not a fit: Patients with metastatic disease, prior systemic therapy for the current breast cancer, poor performance status (ECOG >1), or significant organ dysfunction are unlikely to qualify or derive benefit from this neoadjuvant approach.

Why it matters

Potential benefit: If successful, the experimental regimen could increase tumor response before surgery and provide an additional neoadjuvant option for HER2-positive patients.

How similar studies have performed: Other neoadjuvant regimens combining HER2-targeted antibodies with chemotherapy have improved preoperative tumor response rates, but BL-M07D1 is a novel agent and its benefit in this setting is not yet established.

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.

Where this trial is running

Bengbu, Anhui and 29 other locations

• The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China (NOT_YET_RECRUITING)
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) — Hefei, Anhui, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (NOT_YET_RECRUITING)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (NOT_YET_RECRUITING)
• Guangdong Maternal and Child Health Center — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (NOT_YET_RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• Hainan General Hospital — Haikou, Hainan, China (NOT_YET_RECRUITING)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (NOT_YET_RECRUITING)
• Xingtai People's Hospital — Xingtai, Hebei, China (NOT_YET_RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
• Anyang Cancer Hospital — Anyang, Henan, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Henan University of science and technology — Luoyang, Henan, China (NOT_YET_RECRUITING)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (NOT_YET_RECRUITING)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Shaanxi Provincial People's Hospital — Xi'an, Shaanxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (NOT_YET_RECRUITING)
• Shandong Cancer Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• Sichuan Cancer Hospital — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Tianjin Cancer Hospital — Tianjin, Tianjin Municipality, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions: HER2-positive Breast Cancer