BL-M07D1 plus pertuzumab vs standard therapy in first-line 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 is a randomized, open-label Phase 3 study conducted at multiple centers. It compares BL-M07D1 plus pertuzumab to the standard regimen of docetaxel, trastuzumab, and pertuzumab in first-line HER2-positive recurrent/metastatic breast cancer. Eligible patients have measurable disease, good performance status, and adequate organ function. The trial aims to determine whether the BL-M07D1 combination provides comparable or superior efficacy with an acceptable safety profile. Outcomes include objective response, progression-free survival, and safety signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Female patients aged ≥18 and ≤75 years at the time of signing the informed consent form;
3. Expected survival time ≥12 weeks;
4. Patients with histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer;
5. Clear hormone receptor (HR) status;
6. Agree to provide eligible tumor tissue specimens;
7. Have at least one measurable target lesion as defined by RECIST v1.1;
8. ECOG performance status score of 0 or 1;
9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
10. Organ function levels must meet the requirements;
11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and must be non-lactating; all enrolled patients must use adequate and highly effective contraceptive measures throughout the entire treatment period and for 7 months after treatment completion.

Exclusion Criteria:

1. Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose.
2. Previously received ADC drug therapy with camptothecin derivatives as toxins.
3. History of severe cardiovascular or cerebrovascular disease within six months before screening.
4. Concomitant pulmonary disease resulting in severely impaired lung function.
5. History of interstitial lung disease (ILD)/interstitial pneumonia requiring corticosteroid therapy, etc.
6. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias.
7. Diagnosed with another primary malignancy within 5 years before the first dose.
8. Newly developed deep vein thrombosis within 14 days before screening.
9. Hypertension poorly controlled by antihypertensive medications.
10. Patients with active central nervous system metastases.
11. History of severe allergic reactions to recombinant humanized antibodies or any excipient or component of BL-M07D1.
12. History of autologous or allogeneic stem cell transplantation or organ transplantation.
13. Previously received anthracycline therapy exceeding the prescribed dose limit.
14. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection.
15. Severe infection within 4 weeks prior to the first use of the study drug, etc.
16. Patients with large serous cavity effusions, serous cavity effusions with obvious symptoms, or poorly controlled serous cavity effusions.
17. Receiving systemic corticosteroid therapy \>10 mg/day prednisone or equivalent prior to randomization, etc.
18. Presence of severe neurological or psychiatric disorders.
19. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent.
20. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.
21. Subjects planning to receive or having received live vaccines within 28 days before the first dose.
22. Presence of other serious physical conditions, abnormal laboratory findings, or poor compliance that may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study in the investigator's opinion.

Where it's running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China 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.

• 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

• Neoadjuvant therapy with or without Inavolisib for early HER2-positive breast cancer

  This study is testing if adding a new drug called Inavolisib to standard treatment can help women with early HER2-positive breast cancer respond better before surgery.

  Recruiting at 53 sites Phase 2 GBG Forschungs GmbH · Essen, North Rhine-Westphalia and 61 other locations · NCT05306041

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.