OncoMatch/Clinical Trials/NCT04920708
Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression
Is NCT04920708 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ipatasertib 300mg and Fulvestrant 500g for metastatic breast cancer.
Treatment: Ipatasertib 300mg · Fulvestrant 500g · Palbociclib 75mg-125mg · CDK4/6 Inhibitor — Analysis of circulating tumour DNA (ctDNA) found in a patient's peripheral blood can identify cancer progression and predict a patient's response to therapy. By using ctDNA analysis and imaging techniques, the FAIM trial aims to determine whether the addition of the experimental drug ipatasertib to a standard combination of the hormone treatment fulvestrant and the targeted agent palbociclib increases progression free survival (PFS) for patients with hormone-receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (immunohistochemistry 0/1+ or negative by in situ hybridization)
Required: ESR1 positive (allred score 3/8 or greater, or stain in >1% of cancer cells)
Disease stage
Metastatic disease required
metastatic or inoperable locally advanced ER positive/HER2 negative breast cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hormone therapy — advanced disease
Patients must have received at least one prior line of hormone therapy for advanced disease and progressed on or within 1 month from stopping prior endocrine therapy for advanced disease, or relapsed on or within 12 months of completing adjuvant endocrine therapy.
Cannot have received: fulvestrant (fulvestrant)
Previous fulvestrant ... in any setting.
Cannot have received: CDK4/6 inhibitor (abemaciclib, palbociclib, ribociclib)
Previous ... CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) in any setting.
Cannot have received: AKT inhibitor
Prior use of AKT inhibitor (any setting).
Cannot have received: systemic chemotherapy
Systemic chemotherapy within 14 days prior to study entry.
Lab requirements
Blood counts
Neutrophils (ANC ≥ 1500/μL), Haemoglobin ≥9 g/dL, Platelet count ≥100,000/μL
Kidney function
Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤1.5 x ULN (≤3 x ULN for Gilbert syndrome); AST and ALT ≤2.5 x ULN (≤5 x ULN with liver or bone metastases); ALP ≤2 x ULN (≤5 x ULN with liver involvement, ≤7 x ULN with bone involvement)
Adequate bone marrow, renal, and liver function within 14 days before the first study treatment ... see details in criteria 9
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify