Neoadjuvant BL-M07D1 (with or without pertuzumab) versus taxane + trastuzumab + pertuzumab for HER2-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with protocol requirements;
2. Female aged ≥18 and ≤75 years at the time of signing the informed consent form;
3. Expected survival time ≥6 months;
4. Patients with HER2-positive invasive breast cancer confirmed by histological examination;
5. Clinical stage II-III confirmed based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system before neoadjuvant therapy;
6. Treatment-naive trial participants who have not received any anti-tumor therapy for breast cancer;
7. Trial participants agree to undergo mastectomy or breast-conserving surgery after completion of neoadjuvant therapy;
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
9. Organ function levels must meet the requirements;
10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy must be negative, and the patient must be non-lactating; all enrolled patients should adopt adequate highly effective contraceptive measures throughout the entire treatment cycle and for 7 months after treatment completion.

Exclusion Criteria:

1. History of breast cancer and tumor treatment;
2. Diagnosis of other primary malignancies within 5 years before the first dose;
3. History of severe cardiovascular or cerebrovascular disease within 6 months before screening;
4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
5. Hypertension inadequately controlled with two antihypertensive medications;
6. Concurrent pulmonary disease resulting in severe impairment of pulmonary function;
7. History of interstitial lung disease/interstitial pneumonia requiring steroid therapy, etc.;
8. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
9. Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
10. Patients with poorly controlled blood glucose;
11. Severe infection within 4 weeks before the first use of the study drug; active pulmonary inflammation at screening;
12. Receiving systemic corticosteroid therapy at \>10 mg/day prednisone or equivalent anti-inflammatory activity, or any form of immunosuppressive therapy, within 2 weeks before the first dose;
13. Known hypersensitivity to the study treatment or any study drug excipients or other monoclonal antibodies;
14. Patients unsuitable for receiving the investigational drug;
15. History of autologous or allogeneic stem cell transplantation or organ transplantation;
16. Severe neurological or psychiatric disorders;
17. Subjects with clinically significant bleeding or a significant bleeding tendency within 4 weeks before signing informed consent;
18. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;
19. Subjects planning to receive, or having received, live vaccines within 28 days before the first dose;
20. Presence of other severe physical or laboratory abnormalities or poor compliance, etc., which may increase the risk of participating in the study or interfere with study results, or patients deemed unsuitable for participation in this study by the investigator.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• 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

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: 15013238943

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BL-M07D1 plus pertuzumab vs standard therapy in first-line HER2-positive breast cancer

  A Phase 3 trial tests whether adding BL-M07D1 to pertuzumab is as good as or better than docetaxel plus trastuzumab and pertuzumab in patients with newly diagnosed, unresectable or metastatic HER2-positive breast cancer.

  Recruiting at 2 sites Phase 3 Sichuan Baili Pharmaceutical Co., Ltd. · Guangzhou, Guangdong and 1 other locations · NCT07518173

• IBI354 with or without pertuzumab versus taxane plus trastuzumab and pertuzumab for HER2-positive metastatic breast cancer

  This trial tests whether IBI354, with or without pertuzumab, works better than standard taxane plus trastuzumab and pertuzumab as first-line treatment for adults with HER2-positive unresectable locally advanced or metastatic breast cancer.

  Recruiting Phase 3 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Beijing, Beijing Municipality · NCT07377643

• Vaccine targeting HER2 in locally advanced breast cancer

  This trial will test a vaccine that boosts the immune system to attack HER2-positive breast cancer in adults with locally advanced or high-risk disease.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT06949410

• Neoadjuvant therapy for low-risk HER2-positive breast cancer patients

  This study is testing a new treatment plan for people with low-risk HER2-positive breast cancer to see if combining certain chemotherapy drugs with targeted therapy can work just as well with less intense treatment.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT06722599

• Treatment for hormone receptor positive HER2 positive breast cancer after neoadjuvant therapy

  This study is testing if combining two drugs, trastuzumab and nelatinib, can help people with hormone receptor positive HER2 positive breast cancer who still have cancer after initial treatment feel better compared to the usual combination of trastuzumab and pertuzumab.

  Recruiting Phase 3 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou · NCT05760612

• HER2-targeted vaccine combined with standard chemotherapy for breast cancer

  This study is testing if adding a new vaccine to standard chemotherapy can help people with HER2-positive breast cancer have better treatment results.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT05325632

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.