A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
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Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
243actual
Sites
32
Countries
Canada, Poland, South Korea +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2018-12-21 | actual | When the study began enrolling |
| Primary completion | 2024-11-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-02-26 | estimated | The whole study's end, after follow-up |
| First posted | 2018-11-15 | actual | When this record first appeared on the registry |
| Results posted | 2026-02-02 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Triple Negative Breast Neoplasms
Interventions
- Drug: Durvalumab — also filed as MEDI4736
- Drug: Capivasertib — also filed as AZD5363
- Drug: Oleclumab — also filed as MEDI9447
- Drug: Paclitaxel
- Drug: Trastuzumab deruxtecan — also filed as DS-8201a
- Drug: Datopotamab deruxtecan — also filed as Dato-DXd; DS-1062a
Primary outcome
what the primary-completion date above is the date OFDose Limiting Toxicity (DLT) Events
measured From the time of first dose until completion of the first cycle (28 days for Arms 2-5, 21 days for Arms 6-7 (no safety run-in for Arms 1 and 8))
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-07 · 16.8 MB · Prot_002.pdf
Statistical Analysis Planposted 2024-12-19 · 29.3 MB · SAP_001.pdf
Publications
- PMID 42259988 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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