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RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure

NCT07366840 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2026-01-26

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of RC48 (a HER2 antibody drug conjugate with MMAE payload) in combination with gemcitabine or capecitabine (with or without trastuzumab/inetetamab), for treatment of patients with HER2-positive advanced breast cancer (ABC) who have developed disease progression or intolerance to prior therapy with a topoisomerase I inhibitor antibody-drug conjugate (TOP1i-ADC).

Conditions

Interventions

DRUG

Disitamab Vedotin

2.0mg/kg every two weeks

DRUG

Gemcitabine

1000mg/m2 on days 1 and 8 every three weeks

DRUG

Capecitabine

1000 mg/m2 twice daily on days 1 to14 every three weeks

DRUG

Trastuzumab

6 mg/kg once every three weeks, with an initial loading dose of 8 mg/kg

DRUG

Inetetamab

6 mg/kg once every three weeks, with an initial loading dose of 8 mg/kg

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2028-01-16
Completion
2029-01-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07366840 on ClinicalTrials.gov