RecruitingPhase 2NCT05720260

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

A Randomized, Phase II Study for Premenopausal Metastatic or Locally Advanced Breast Cancer Patients: Capivasertib, Goserelin, Fulvestrant With/Without Durvalumab, Versus Goserelin, Fulvestrant, and Durvalumab, Versus Goserelin/ Fulvestrant.


Sponsor

National Taiwan University Hospital

Enrollment

42 participants

Start Date

Jan 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — immunotherapy (a PD-1 inhibitor), hormone therapy (an aromatase inhibitor), and a targeted drug that blocks a growth pathway (an AKT inhibitor) — for premenopausal women with hormone receptor-positive advanced breast cancer that has stopped responding to standard hormone-blocking treatments. **You may be eligible if...** - You are a premenopausal or perimenopausal woman over 20 years old - You have confirmed hormone receptor-positive (ER+) advanced or metastatic breast cancer - Your cancer has become resistant to at least one hormonal treatment (either relapsed during adjuvant therapy or within 2 lines of therapy for advanced disease) - You have not received chemotherapy for your advanced disease - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You are postmenopausal - You have received prior chemotherapy for advanced or metastatic disease - You are pregnant or breastfeeding - Your tumor does not have the hormone receptor positivity profile required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGoserelin

Hormone therapy

DRUGFulvestrant

Hormone therapy

DRUGCapivasertib

AKT inhibitor

DRUGDurvalumab

immunotherapy


Locations(1)

Department of Oncology, National Taiwan University Hospital

Taipei, Taiwan

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NCT05720260


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