A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer

Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer: A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and anti-tumor activity of novel therapeutics in patients with early relapsed metastatic triple-negative breast cancer

Trial Details

NCT ID
NCT06508216
Phase
PHASE1 / PHASE2
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Dato-DXd
  • Durvalumab
Locations (sample)
  • Villejuif, France|48.7939,2.35992

Key Eligibility Criteria

  • Male or female patients (who are ≥18 years of age at the time of signing the informed consent) who have a pathologically documented breast cancer t…
  • Advanced/unresectable (patients who can be treated with curative intent are not eligible) or metastatic.
  • HER2-negative (IHC 0, 1+ or IHC 2+/ISH-) based on local assessment according to ASCO/CAP guidelines 1.
  • Documented as hormone receptor-negative (both oestrogen receptors and progesterone receptors are negative \[oestrogen receptors and progesterone re…

For full eligibility, visit ClinicalTrials.gov.

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