A Randomized Controlled Phase III Clinical Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

Plain English Summary

A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer is a Phase 3 clinical trial sponsored by Sichuan Baili Pharmaceutical Co., Ltd. studying HER2-positive Breast Cancer. This trial tests a new drug combination (BL-M07D1 with pertuzumab) against a standard treatment (docetaxel, trastuzumab, and pertuzumab) for advanced HER2-positive breast cancer. It is for patients with HER2-positive breast cancer that has returned or spread and has not been previously treated with these specific therapies. Participants will be randomly assigned to receive either the new combination or the standard treatment, with no blinding. Alternative treatments may include other chemotherapy regimens, targeted therapies, or participation in different clinical trials. The trial aims to enroll 596 participants.

Official Summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients aged 18-75 with HER2-positive breast cancer that has spread or returned and hasn't been treated with these specific drugs. Must have at least one measurable tumor and good general health (ECOG 0 or 1), with prior treatment side effects resolved. Cannot have certain recent treatments, severe heart or lung conditions, active brain metastases, or a history of severe allergic reactions to similar drugs. This trial is studying HER2-positive Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

Progression-free survival (PFS) measures how long patients live without their cancer getting worse, indicating how well the treatment controls the disease. The specific primary outcome measures are: Progression-free survival (PFS) (Up to approximately 24 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to find a more effective first-line treatment for patients with advanced HER2-positive breast cancer, addressing a need for improved outcomes in this aggressive form of the disease. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets HER2-positive Breast Cancer, where improved treatment options are needed.

Investor Insight

This Phase III trial for a novel combination therapy in a significant breast cancer subtype suggests a potential new standard of care, indicating a competitive market with opportunities for innovative Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 596 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific drugs being tested, potential side effects, and how the new treatment compares to standard options. Participation involves regular clinic visits for treatment infusions, monitoring, and tests over approximately 3 years. You will need to use effective birth control during and after treatment. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 596 participants

Interventions

• DRUG: BL-M07D1 — Administration by intravenous infusion for a cycle of 3 weeks.
• DRUG: Pertuzumab — Administration by intravenous infusion for a cycle of 3 weeks.
• DRUG: Trastuzumab — Administration by intravenous infusion for a cycle of 3 weeks.
• DRUG: Docetaxel — Administration by intravenous infusion for a cycle of 3 weeks.

Primary Outcomes

• Progression-free survival (PFS) (Up to approximately 24 months)

Secondary Outcomes

• Overall survival (OS) (Up to approximately 24 months)
• Objective Response Rate (ORR) (Up to approximately 24 months)
• Duration of Response (DOR) (Up to approximately 24 months)
• Disease Control Rate (DCR) (Up to approximately 24 months)
• Clinical Benefit Rate(CBR) (Up to approximately 24 months)

Full Eligibility Criteria

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.

Trial Locations

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

Frequently Asked Questions

Related Conditions

• Breast Cancer
• HER2-positive Breast Cancer
• Metastatic Breast Cancer
• Recurrent Breast Cancer
• HER2-positive Solid Tumors
• Advanced Breast Cancer
• Hormone Receptor-positive Breast Cancer
• Triple-negative Breast Cancer
• Oncology
• Medical Oncology

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