Comparing two treatments for advanced HER2-positive breast cancer

A Randomized Controlled Phase III Clinical Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

This study is testing whether a new treatment called BL-M07D1 works better than T-DM1 for people with advanced HER2-positive breast cancer who haven't had success with other therapies.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, trastuzumab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06316531 on ClinicalTrials.gov

What this trial studies

This phase III, randomized, open-label, multicenter study evaluates the efficacy and safety of BL-M07D1 compared to T-DM1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who have previously failed treatment with taxanes and trastuzumab. The study aims to determine which treatment provides better outcomes for this patient population. Participants will be monitored for their response to treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable locally advanced or metastatic HER2-positive breast cancer who have not responded to prior therapies.

Not a fit: Patients with severe cardiac dysfunction or those who have not had their toxicity from previous treatments return to grade 1 or lower may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced HER2-positive breast cancer.

How similar studies have performed: Other studies have shown promising results with similar treatment approaches in HER2-positive breast cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent and follow the requirements of the protocol;
2. No gender limit;
3. Age ≥18 years old and ≤75 years old at the time of signing the informed consent;
4. expected survival time ≥3 months;
5. Patients with histologically or cytologically confirmed, unresectable, locally advanced or metastatic HER2-positive breast cancer;
6. Provide the latest tumor tissues to the central laboratory for HER2 and HR detection;
7. Must have at least one measurable target lesion that meets the RECIST v1.1 definition;
8. ECOG 0 or 1;
9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. Blood transfusion is not allowed within 14 days before the first use of the study drug, and no cell growth factor is allowed;
12. Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT)≤1.5×ULN;
13. Urine protein ≤2+ or \< 1000mg/24h;
14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 7 months after the end of treatment.

Exclusion Criteria:

1. Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the first dose, received surgery, chemotherapy, immunotherapy, etc. Within 4 weeks before the first dose, received endocrine therapy, palliative radiotherapy, and anti-tumor therapy approved by NMPA within 2 weeks before the first dose;
2. Previous use of HER2-ADC in the metastatic background;
3. Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin;
4. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
5. Complicated with pulmonary diseases leading to severe impairment of lung function;
6. History of ILD/interstitial pneumonia, current ILD/interstitial pneumonia, or suspected ILD/interstitial pneumonia; According to CTCAE v5.0 was defined as ≥ grade 3 pulmonary disease and ≥ grade 2 radiation pneumonitis;
7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
8. Other primary malignancies diagnosed within 5 years before the first dose;
9. Poorly controlled hypertension (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg);
10. Patients with active central nervous system metastases;
11. Patients with a history of allergy to recombinant humanized antibody or to any of the excipents of BL-M07D1;
12. Patients with known hypersensitivity or delayed hypersensitivity to certain components of T-DM1 or similar drugs, or known contraindications to T-DM1;
13. History of autologous or allogeneic stem cell transplantation or organ transplantation;
14. Anthracycline-equivalent cumulative dose of adriamycin \> 360 mg/m2;
15. Human immunodeficiency virus antibody positive, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;
16. Serious infection within 4 weeks before the first dose of study drug; There was active pulmonary inflammation at the time of screening;
17. Patients with massive or symptomatic effusions or poorly controlled effusions;
18. Receiving active antiinflammatory drugs or any form of immunosuppressive therapy before randomization;
19. A history of severe neurological or psychiatric illness;
20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
21. Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;
22. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;
23. Patients who were deemed by the investigator to be ineligible for the study.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Erwei Song — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Sa Xiao, PHD

Conditions HER2-positive Breast Cancer