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BRIGHTRC48 and Chemotherapy for HER2-Positive Advanced Breast Cancer Post-TOP1i-ADC Failure

Study Aim

This study aims to evaluate the effectiveness of RC48 in combination with chemotherapy for treating advanced breast cancer in individuals who have a HER2-positive gene expression and have not responded to previous TOP1i-ADC treatment.

What is being tested

Disitamab Vedotin

+ Gemcitabine

+ Capecitabine

Drug

Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorFudan University

Study ContactJian Zhang, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 16, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on treating advanced breast cancer that is HER2-positive and has not responded well to previous treatments. The study aims to find a better treatment option for patients who have tried a specific type of therapy called TOP1i-ADC, but their cancer continued to grow or they couldn't tolerate the side effects. The trial is important because it could lead to improved care for patients with this type of breast cancer who currently have limited treatment options. The study is divided into two parts. In the first part, a small group of patients will receive one of two treatment combinations to see which one works better and is safer. The treatments include a new drug called RC48 combined with either Gemcitabine or Capecitabine, with or without Trastuzumab or Inetetamab. The second part of the study is larger and will compare the best treatment found in the first part to the current standard treatment. Patients will be randomly assigned to receive either the new treatment or the standard treatment. The study will measure how well the treatments shrink tumors and how safe they are for patients.

Official TitleA Phase 3, Randomized Advanced Breast Cancer Study Investigating RC48 Combined With Chemotherapy Versus Guideline-recommended Trastuzumab/Inetetamab Plus Chemotherapy in HER2-Positive Patients With Prior TOP1i-ADC Failure

NCT07366840

Principal SponsorFudan University

Study ContactJian Zhang, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

268 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

11 inclusion criteria required to participate

At least one extracranial measurable lesion according to RECIST v1.1 criteria.

ECOG Performance Status (PS) of 0 or 1.

Adequate function of major organs, meeting the following criteria:Hematological criteria:Hemoglobin (HB) ≥ 90 g/L (no blood transfusion within 14 days prior);Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L;Platelet count (PLT) ≥ 75 × 10⁹/L.Biochemical criteria:Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN; for subjects with liver metastases, ALT and AST ≤ 5 × ULN;Serum Creatinine (Cr) ≤ 1 × ULN, and calculated Creatinine Clearance Rate (Ccr) > 50 mL/min (using the Cockcroft-Gault formula).

Female subjects aged ≥ 18 years.

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10 exclusion criteria prevent from participating

A history of other malignancies within 3 years prior (except for bilateral breast cancer with HER2 positivity in both lesions, cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, papillary thyroid carcinoma with favorable prognosis, or carcinoma in situ of the lung or minimally invasive adenocarcinoma with favorable prognosis).

Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in the study.

Unstable brain metastases, leptomeningeal metastases, or untreated brain metastases (excluding subjects with treated and stable brain metastases who have been asymptomatic for ≥ 4 weeks).

A history of arterial or venous thromboembolic events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 3 years prior to the start of study treatment.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants received Disitamab Vedotin (RC48), 2.0mg/kg intravenously on day 1 of two-week cycle, plus chemotherapy of physician's choice (gemcitabine 1000mg/m2, intravenously on days 1 and 8 of 21-day cycle, or capecitabine, 1000 mg/m2, orally twice daily on days 1-14 of 21-day cycle), with or without guideline-recommended anti-HER2 monoclonal antibody (Trastuzumab or Inetetamab (an analog of trastuzumab), 8 mg/kg loading dose, intravenously, then 6 mg/kg without loading dose, on day 1 of 21-day cycle) until physician's verified progression or unacceptable toxicity.

Group II

Experimental

Participants received chemotherapy of physician's choice (gemcitabine 1000mg/m2, intravenously on days 1 and 8 of 21-day cycle, or capecitabine, 1000mg/m2, orally twice daily on days 1-14 of 21-day cycle), with or without guideline-recommended anti-HER2 monoclonal antibody (Trastuzumab or Inetetamab (an analog of trastuzumab), 8 mg/kg loading dose, intravenously, then 6 mg/kg without loading dose, on day 1 of 21-day cycle) until physician's verified progression or unacceptable toxicity.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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