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

Official title

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

Overview

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.

Detailed description

In this trial, the treatment group receives BL-M07D1 and pertuzumab, while the control group receives trastuzumab, pertuzumab, and docetaxel.

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 outcome measures

• Progression-free survival (PFS) [Time frame: Up to approximately 24 months]

Secondary outcome measures (7)

• Overall survival (OS) [Time frame: Up to approximately 24 months]
• Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
• Duration of Response (DOR) [Time frame: Up to approximately 24 months]
• Disease Control Rate (DCR) [Time frame: Up to approximately 24 months]
• Clinical Benefit Rate(CBR) [Time frame: Up to approximately 24 months]
• Treatment Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]
• Anti-drug antibody (ADA) [Time frame: Up to approximately 24 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Patients with large serous cavity effusions, serous cavity effusions with obvious symptoms, or poorly controlled serous cavity effusions.
• Receiving systemic corticosteroid therapy >10 mg/day prednisone or equivalent prior to randomization, etc.
• Presence of severe neurological or psychiatric disorders.
• Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent.
• Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.
• Subjects planning to receive or having received live vaccines within 28 days before the first dose.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

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

Identifiers

NCT: NCT07518173 · BL-M07D1-307

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗