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

NCT07518173 | Recruiting Phase 3 DMC

• 1 other identifier: BL-M07D1-307
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

  Up to approximately 24 months

Secondary Outcomes (7)

• 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

Study Arms (2)

BL-M07D1 + Pertuzumab

EXPERIMENTAL

Participants receive BL-M07D1 + Pertuzumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-M07D1; Drug: Pertuzumab

Docetaxel + Trastuzumab + Pertuzumab

ACTIVE COMPARATOR

Participants receive Docetaxel + Trastuzumab + Pertuzumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: Pertuzumab; Drug: Trastuzumab; Drug: Docetaxel

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1 + Pertuzumab

Pertuzumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1 + Pertuzumab; Docetaxel + Trastuzumab + Pertuzumab

Trastuzumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Docetaxel + Trastuzumab + Pertuzumab

Docetaxel DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Docetaxel + Trastuzumab + Pertuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Female patients aged ≥18 and ≤75 years at the time of signing the informed consent form;
• Expected survival time ≥12 weeks;
• Patients with histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer;
• Clear hormone receptor (HR) status;
• Agree to provide eligible tumor tissue specimens;
• Have at least one measurable target lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• Organ function levels must meet the requirements;
• 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.

You may not qualify if:

• Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose.
• Previously received ADC drug therapy with camptothecin derivatives as toxins.
• History of severe cardiovascular or cerebrovascular disease within six months before screening.
• Concomitant pulmonary disease resulting in severely impaired lung function.
• History of interstitial lung disease (ILD)/interstitial pneumonia requiring corticosteroid therapy, etc.
• QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias.
• Diagnosed with another primary malignancy within 5 years before the first dose.
• Newly developed deep vein thrombosis within 14 days before screening.
• Hypertension poorly controlled by antihypertensive medications.
• Patients with active central nervous system metastases.
• History of severe allergic reactions to recombinant humanized antibodies or any excipient or component of BL-M07D1.
• History of autologous or allogeneic stem cell transplantation or organ transplantation.
• Previously received anthracycline therapy exceeding the prescribed dose limit.
• Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection.
• Severe infection within 4 weeks prior to the first use of the study drug, etc.

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Interventions

pertuzumab; Trastuzumab; Docetaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

CN (2)