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

Sponsor
National Taiwan University Hospital
Study ID
NCT05720260
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Goserelin — DRUG
    Hormone therapy
  • Fulvestrant — DRUG
    Hormone therapy
  • Capivasertib — DRUG
    AKT inhibitor
  • Durvalumab — DRUG
    immunotherapy

Study Details

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/ durvalumab (Arm B), or goserelin/ fulvestrant/ capivasertib (Arm C) at a 1:1:1 ratio. The primary endpoint is objective response rate (ORR) of the whole other three arm compared to historical goserelin/ fulvestrantcontrol arm. The major secondary endpoint will be progression-free survival or ORR compared among different treatment arms.

Key Dates

Start date
Jan 17, 2023
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Jan 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: goserelin/ fulvestrant/ durvalumab
    Historical control arm (goserelin, fulvestrant) plus immunotherapy
  • Experimental: Arm B: goserelin/ fulvestrant/ capivasertib/ durvalumab
    Historical control arm (goserelin, fulvestrant) plus AKT inhibitor and immunotherapy
  • Experimental: Arm C: goserelin/ fulvestrant/ capivasertib
    Historical control arm (goserelin, fulvestrant) plus AKT inhibitor and immunotherapy

Primary Outcome Measure

Progression-free survival [ Time Frame: From time of randomization to death or tumor progression whichever comes first in 200 months ]

Central Contacts

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