Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age20+
SponsorNational Taiwan University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 (ii) or resistant to prior hormonal therapy (failed ≤ 2lines of hormonal therapy for locally advanced or metastatic breast cancer)
Disqualifiers
Prior therapy with capivasertib, fulvestrant, anti-PD1 or anti-PDL1 immunotherapy
Prior chemotherapy for locally advanced or metastatic breast cancer.
Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment
The tumor is HER-2 positive by IHC 3+ or IHC 2+/ISH positive.
Trial design
Design model
Parallel
Treatments tested in this trial
Goserelin
DrugHormone therapy
Fulvestrant
DrugHormone therapy
Capivasertib
DrugAKT inhibitor
Durvalumab
Drugimmunotherapy
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: Arm A: goserelin/ fulvestrant/ durvalumabExperimental treatment 3 interventions
Group B: Arm B: goserelin/ fulvestrant/ capivasertib/ durvalumabExperimental treatment 4 interventions
Group C: Arm C: goserelin/ fulvestrant/ capivasertibExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival
PFS comparison between historical control (fulvestrant and goserelin) and Arm A/B/C
Time frame
From time of randomization to death or tumor progression whichever comes first in 200 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov