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Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

StatusRecruiting
PhasePhase 2
Started2024-10-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
notable
Study Status, Arms and Interventions v5
Trial arms changed: 8 → 10
Interventions modified
2026-04-02
minor
Study Identification, Study Status, Study Description, Outcome Measures v4
Secondary endpoints5 to 6 entries
Disease Control Rate (DCR)
Study description-14 characters
This is a prospective, open-label, multicenter, phase II2 platform trial. The purpose of this study is to test the sa [...]
2026-03-15
minor
Study Status, Study Description, Study Design, Arms and Interventions v3
Enrollment target120→160
Study arms6→8
InterventionsFamitinib (Drug), Fat Module Formula for Special Medical Purposes (Dietary Supplement), SHR-A1811 (Drug), SHR-A1921 (Drug), SHR-A2009…→9MW2821 (Drug), Famitinib (Drug), Fat Module Formula for Special Medical Purposes (Dietary Supplement), SHR-A1811 (Drug), SHR-A1921 (Drug)…
Study description-193 characters
[...] 1921 (TROP2 ADC), SHR-A2009 (HER3 ADC) and SHR-A2102 (Nectin-4 ADC). This platform trial is adaptive design. Novel ADC re [...] d target, the subjects were randomly assigned to each cohort by adaptive randomization. On the basis of previous clinical data at our center, we l [...] ional 10 results according to the Bayesian monitoring method, and the proportion of random assignment to each cohort will be adjusted according to the calculated posterior probability using response-adaptive randomization (RAR). Graduation (successful validation) or elimination (failed [...]
2025-11-17
minor
Study Status, Oversight, Arms and Interventions, Contacts/Locations v2
Study arms4→6
InterventionsSHR-A1811 (Drug), SHR-A1921 (Drug), SHR-A2009 (Drug), SHR-A2102 (Drug)→Famitinib (Drug), Fat Module Formula for Special Medical Purposes (Dietary Supplement), SHR-A1811 (Drug), SHR-A1921 (Drug), SHR-A2009…
Study sitescontacts updated at 1 of 1 site
2024-12-08
minor
Study Status, Oversight, Contacts/Locations v1
Study sitescontacts updated at 1 of 1 site
2024-10-17
minor
Original filing
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.
Trial Details
NCT Number NCT06649331
Lead Sponsor Fudan University
Conditions Advanced Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2-negative Breast Cancer, Breast Cancer
Enrollment 160 participants
Start Date 2024-10-21
Primary Completion 2026-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-03