Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05831878

RC48-ADC in HER2-low Advanced Breast Cancer

Led by RenJi Hospital · Updated on 2026-05-13

36

Participants Needed

1

Research Sites

238 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.

CONDITIONS

Official Title

RC48-ADC in HER2-low Advanced Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged  18 years
  • Expected survival of at least 12 weeks
  • ECOG performance status of 0 or 1
  • Histologically confirmed invasive advanced or metastatic breast cancer that cannot be cured or removed by surgery
  • At least one measurable tumor lesion according to RECIST 1.1 criteria
  • No prior use of antibody-drug conjugates
  • Received up to one previous chemotherapy for advanced disease
  • Available hormone receptor status; hormone receptor-positive patients may have received up to two previous endocrine therapies for advanced disease
  • HER2-low tumors defined as IHC1+ or IHC2+ with negative FISH test, or HER2-ultralow tumors with incomplete and faint membrane staining in more than 0 but  10% of tumor cells
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • History of thromboembolic events
  • Uncontrolled systemic diseases such as diabetes, hypertension, interstitial lung disease, or cirrhosis
  • Active infections requiring systemic treatment
  • Pregnant or breastfeeding
  • Presence of brain metastases or carcinomatous meningitis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China, 200127

Actively Recruiting

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Research Team

W

Wenjin Yin, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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