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Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
Sponsor: Fudan University
Summary
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.
Official title: Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer:A Prospective, Open-label, Phase 2 Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2024-10-21
Completion Date
2027-09
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
SHR-A1811
A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
SHR-A1921
A TROP2-directed ADC, via intravenous (into the vein) infusion per protocol.
SHR-A2009
A HER3-directed ADC, via intravenous (into the vein) infusion per protocol.
SHR-A2102
A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.
Famitinib
A VEGFR inhibitor administered orally per the protocol.
Fat Module Formula for Special Medical Purposes
This nutritional formulation is composed primarily of medium-chain triglycerides (MCT), which are metabolized by the liver to induce nutritional ketosis, thereby significantly elevating circulating levels of beta-hydroxybutyrate (BHB).
Trastuzumab (or biosimilar)
An anti-HER2 antibody, via intravenous (into the vein) infusion or subcutaneous per protocol.
9MW2821
A Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.
Disitamab Vedotin (RC48)
A HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
Treatment of physician's choice (TPC)
Treatment of physician's choice (TPC), such as nab-paclitaxel, carboplatin, gemcitabine, capecitabine, vinorelbine, eribulin, etc., with specific dosages and administration methods determined at the investigator's discretion.
Locations (1)
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China