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

What Was Tested

The trial (phase 2) is built around Goserelin.

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.

It had three arms (groups): Arm A: goserelin/ fulvestrant/ durvalumab (experimental), Arm B: goserelin/ fulvestrant/ capivasertib/ durvalumab (experimental) and Arm C: goserelin/ fulvestrant/ capivasertib (experimental).

Historical control arm (goserelin, fulvestrant) plus immunotherapy.

Historical control arm (goserelin, fulvestrant) plus AKT inhibitor and immunotherapy.

Historical control arm (goserelin, fulvestrant) plus AKT inhibitor and immunotherapy.

The registry classes the interventions as drug.

More on the Plan

The primary endpoint is objective response rate (ORR) of the whole other three arm compared to historical goserelin/ fulvestrant control arm.

Secondary endpoints include PFS and ORR comparison between arms.

Exploratory endpoints include biomarkers, such as TILs, PD-L1 correlation with treatment response.

Who Took Part

Enrollment: 42 planned participants were the target.

It was open to women only aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 must have adequate organ and marrow reserve measured within 14 days(within screening period ) prior to randomization as defined below:. Absolute neutrophil count ≥ 1,500 /L;. Platelets ≥ 100,000/L;.

The full record lists 21 inclusion and 41 exclusion criteria; among the exclusions: prior therapy with capivasertib, fulvestrant, anti-pd1 or anti-pdl1 immunotherapy; prior chemotherapy for locally advanced or metastatic breast cancer; the tumor is her-2 positive by ihc 3+ or ihc 2+/ish positive.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.

The Goserelin group and the comparison group ran side by side rather than switching.

Being open-label, the Goserelin study did not mask who received what.

It started in 2023-01-17 with completion listed for 2024-12-31.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression-free survival.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 42 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.