RecruitingPhase 3NCT06957886

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer

A Randomized, Controlled Phase III Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

566 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new antibody-drug combination (BL-M07D1) against standard chemotherapy in women with HER2-low breast cancer that has come back or spread. HER2-low means the tumor has a small amount of the HER2 protein — not enough to be considered HER2-positive, but enough to be targeted by this new type of treatment. **You may be eligible if...** - You are a woman aged 18 to 75 - You have been diagnosed with advanced (unresectable, locally recurrent, or metastatic) HER2-low breast cancer - Your cancer has been previously treated with chemotherapy and hormone therapy (if applicable) - You have at least one measurable tumor lesion on imaging - Your overall health is good (ECOG 0–1) - Your organ function (liver, kidneys, blood counts) meets the study requirements **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your cancer is HER2-positive or HER2-zero (no HER2 expression at all) - You have untreated brain metastases - You have received more than the allowed number of prior treatment lines Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGCapecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel

Oral administration of Capecitabine. Administration by intravenous infusion of Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel.


Locations(2)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Hunan Cancer Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT06957886


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