Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC

This is an open-label randomized phase II study in estrogen receptor positive locally advanced or metastatic breast cancer patients. The main inclusion population are either luminal subtype B by PAM50 analysis or failed less than 2 lines of hormonal therapy for locally advanced or metastatic breast cancer. The subjects have to be premenopausal or perimenopausal and are not allowed to receive any systemic chemotherapy for their locally advanced or metastatic breast cancer. Eligible subjects will be randomized into goserelin/ fulvestrant/ durvalumab (Arm A), goserelin/ fulvestrant/ capivasertib/

Trial Details

NCT ID
NCT05720260
Phase
PHASE2
Sponsor
National Taiwan University Hospital
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Goserelin
  • Fulvestrant
  • Capivasertib
  • Durvalumab
Locations (sample)
  • Taipei, Taiwan|25.05306,121.52639

Key Eligibility Criteria

  • A histological confirmed ER positive (\>1%) invasive breast cancer.
  • Locally advanced or metastatic disease with at least one measurable target lesion
  • Patients who had not received chemotherapy for locally advanced or metastatic disease
  • Patients have to be (i) either primary resistant to hormonal therapy defined as recurrence developed within 2 years of adjuvant hormonal therapy (i…

For full eligibility, visit ClinicalTrials.gov.

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