RecruitingPhase 3NCT06830889

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

A Randomized Controlled Phase Ill Clinical Study of BL-M07D1 for Injection Versus Trastuzumab Emtansine (T-DM1) in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

1,450 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a new antibody-drug therapy (BL-M07D1) to the standard treatment (T-DM1) in women with HER2-positive breast cancer who had cancer remaining after their pre-surgery (neoadjuvant) treatment. **You may be eligible if...** - You are a woman aged 18–75 with confirmed HER2-positive invasive breast cancer - Your cancer stage before neoadjuvant therapy was T1–T4, N0–N3, M0 (excluding T1N0) - You still had invasive cancer in the breast or lymph nodes after your surgery - You completed a qualifying course of neoadjuvant chemotherapy plus anti-HER2 therapy - Your radical surgery was completed 3–12 weeks before starting the study drug - Your ECOG score is 0 or 1 and prior treatment side effects have mostly resolved **You may NOT be eligible if...** - You had a complete pathologic response (no cancer remaining) after surgery - You did not complete the required neoadjuvant therapy - You are pregnant, breastfeeding, or not using effective contraception - You received a blood transfusion or colony-stimulating factors within 14 days before the first dose 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.

DRUGT-DM1

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(2)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06830889


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