OncoMatch/Clinical Trials/NCT05720260
Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC
Is NCT05720260 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Goserelin and Fulvestrant for premenopausal breast cancer.
Treatment: Goserelin · Fulvestrant · Capivasertib · Durvalumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>1%)
A histological confirmed ER positive (>1%) invasive breast cancer
Excluded: HER2 (ERBB2) overexpression
The tumor is HER-2 positive by IHC 3+ or IHC 2+/ISH positive [excluded]
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: hormonal therapy — adjuvant or advanced/metastatic
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)
Cannot have received: chemotherapy
Exception: chemotherapy for locally advanced or metastatic disease only
Patients who had not received chemotherapy for locally advanced or metastatic disease
Cannot have received: chemotherapy
Exception: chemotherapy for locally advanced or metastatic disease only
Prior chemotherapy for locally advanced or metastatic breast cancer
Cannot have received: AKT inhibitor (capivasertib)
Prior therapy with capivasertib
Cannot have received: antiestrogen (fulvestrant)
Prior therapy with fulvestrant
Cannot have received: anti-PD-1 therapy
Prior therapy with anti-PD1
Cannot have received: anti-PD-L1 therapy
Prior therapy with anti-PDL1 immunotherapy
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1,500 /L; Platelets ≥ 100,000/L; aPTT < 1.5 x upper normal limit (unless on therapeutic anti-coagulation)
Kidney function
Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≧50ml/min; Proteinuria ≤ 1+ with urine dipstick, if > 1+, 24-hour urine protein must be ≤ 1 g
Liver function
Total bilirubin ≤ 1.5 x upper normal limit; AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≤ 5 x upper normal limit is allowed
Cardiac function
Mean resting corrected QT interval (QTc) >470 msec obtained from 3 consecutive ECGs; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG; Any factors that increase the risk of QTc prolongation or risk of arrhythmic events; Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram; Uncontrolled hypotension - SBP <90 mmHg and/or DBP <50 mmHg; Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA grade ≥2
Patients must have adequate organ and marrow reserve measured within 14 days(within screening period ) prior to randomization as defined below: Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1,500 /L; Platelets ≥ 100,000/L; Total bilirubin ≤ 1.5 x upper normal limit; AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≤ 5 x upper normal limit is allowed; Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≧50ml/min; aPTT < 1.5 x upper normal limit (unless on therapeutic anti-coagulation); Proteinuria ≤ 1+ with urine dipstick, if > 1+, 24-hour urine protein must be ≤ 1 g. Any of the following cardiac criteria at screening: Mean resting corrected QT interval (QTc) >470 msec obtained from 3 consecutive ECGs; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block); Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval; Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥2; Uncontrolled hypotension - SBP <90 mmHg and/or DBP <50 mmHg; Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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