Actively Recruiting
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
Led by Fudan University · Updated on 2026-04-08
160
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs.
CONDITIONS
Official Title
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with locally advanced breast cancer unsuitable for surgery or recurrent metastatic breast cancer
- Previously treated with antibody-conjugated drugs (ADCs)
- Recent pathology results available for ER, PR, and HER2 status; all hormone receptor statuses allowed
- If hormone receptor positive, must have received prior CDK4/6 inhibitor therapy
- Measurable disease per RECIST 1.1 criteria
- Normal main organ functions including blood counts, liver and kidney function, and heart ejection fraction of 50% or higher
- No radiotherapy, targeted therapy, or surgery within 3 weeks before study start, and recovered from previous treatment toxicities
- No peripheral neuropathy or only grade I peripheral neurotoxicity
- ECOG performance status of 0 to 2 and life expectancy of at least 3 months
- Fertile female participants must use medically approved contraception during and for 3 months after treatment
- Willing to sign informed consent and comply with study procedures and follow-up
You will not qualify if you...
- Radiotherapy, chemotherapy, or immunotherapy within 3 weeks before treatment start (except bisphosphonates for bone metastasis)
- Uncontrolled or symptomatic central nervous system metastases
- History of serious or uncontrolled heart disease within the past 6 months
- Uncontrollable fluid buildup such as ascites or pleural effusion
- Use of immunosuppressive agents or systemic corticosteroids (above 10 mg prednisone daily) within 2 weeks before first dose, excluding nasal or inhaled steroids
- Active or history of autoimmune disease with potential relapse
- Known uncontrolled HIV infection
- Active hepatitis B or C infection
- Persistent grade 1 or higher side effects from previous treatments, except hair loss or conditions deemed acceptable by investigators
- Major surgery within 3 weeks prior to trial treatment, except minor outpatient procedures
- Pregnant or breastfeeding
- History of other cancers within past 5 years, except cured basal cell carcinoma or cervical carcinoma in situ
- Allergic reactions to agents similar to study drugs or their supportive medications
- Serious physical or mental health conditions or lab abnormalities that increase study risk or interfere with results
- Considered ineligible by the investigator for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, M.D.
CONTACT
X
Xiyu Liu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here