Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Wit… (NCT04920708) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression
United Kingdom57 participantsStarted 2022-12-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histological diagnosis of metastatic or inoperable locally advanced ER positive/HER2 negative breast cancer. Assessment of ER and HER2 status as per local assessment. Histologically proven primary ER+ (Allred score 3/8 or greater, or stain in more than 1% of cancer cells) and HER2- (immunohistochemistry 0/1+ or negative by in situ hybridization) breast cancer as determined by local laboratory.
✓. Willingness to consent for an archival tumour tissue sample (of advanced disease) to be requested for transfer to the Royal Marsden during study screening for future analysis. Patients without a metastatic biopsy are eligible if archival tumour from the breast primary tumour is available, but only after discussion with the Chief Investigator (see section 7.3.1). (PI assessment that a biopsy is not clinically appropriate will be required as evidence before discussion with the CI).
✓. Previously treated with no more than one prior line of chemotherapy for advanced disease.
✓. Patients eligible according to standard of care for fulvestrant in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib).
✓. Patients must have 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.
✓. Measurable disease according to RECIST 1.1 or assessable bone disease (lytic or mixed lytic/sclerotic).
What they're measuring
1
Assess progression free survival (PFS)
Timeframe: Time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 51 months
. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
✓. Adequate bone marrow, renal, and liver function within 14 days prior to the first study treatment on Day 1 of Cycle 1, defined as:
Exclusion criteria
✕. Prior exposure to adjuvant CDK4/6 inhibitors (abemaciclib, palbociclib, or ribociclib) for early breast cancer less than 12 months (52 weeks or 365 days) prior to breast cancer recurrence.
✕. Prior treatment with fulvestrant for advanced breast cancer.
✕. Prior treatment with an AKT inhibitor, PIK3CA inhibitor, or mTOR inhibitor in any setting.
✕. History of malabsorption syndrome or other condition that would interfere with enteral absorption, or inability or unwillingness to swallow oral medication.
✕. Systemic chemotherapy within 14 days or endocrine therapy within 7 days prior to registration.
✕. Major surgery within 4 weeks prior to registration.
✕. Palliative radiotherapy within 14 days prior to registration.
✕. Known leptomeningeal disease, untreated brain metastases, spinal cord compression, or symptomatic brain metastases requiring steroids.