MA40

MA40 Details
Status: Open
Activation Date: 2020DEC01
Phase: III

Description: A Double-Blind Placebo Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor (FINER)

Eligibility: INCLUSION CRITERIA: Histologically/cytologically confirmed ER+, HER2- breast cancer. Females must be post-menopausal or pre-menopausal with ovarian supression using LHRH agonist. Clinical/radiographic progression during treatment with/within 28 days of discontinuation of 1st line treatment with CDK4/6 inhibitor and AI for advanced disease. Clinicallyradiologically documented disease. 18 years of age or older. ECOG 0 or 1. No concurrent anti-cancer therapy. Must not have received > 1 prior line of treatment with a CDK 4/6 inhibitor + AI in advanced setting. Treatment with CDK 4/6 inhibitor + AI must be most recent treatment. Adequate hematology and organ function.MAIN EXCLUSION CRITERIA: Untreated or symptomatic CNS metastases, radiation for CNS within 28 days. Active inflammatory bowel disease. Prior treatment with fulvestrant, SERDs or PI3K inhibitors. QTc>/=480 msec. Active infections. Type 1/2 diabetes requiring insulin. Hypercholesterolemia. Coagulation disorders.

Objective: PRIMARY: Investigator assessed PFS (per RECIST 1.1) in ipatasertib + fulvestrant vs. placebo + fulvestrant arms SECONDARY: compare treatment arms with respect to investigator assessed PFS in PIK3CA/AKT1/PTEN altered cohort, investigator assessed PFS in non-altered PIK3CA/AKT1/PTEN cohort, PFS as assessed by blinded central radiology review in all patients, response rate (RR) [per RECIST 1.1], duration of response (DoR), clincial benefit rate (CBR), overall survival (OS), time to commencement of subsequent line systemic therapy or death (TSST), safety and tolerability (CTCAE version 5.0). quality of life (QOL) (EORTC QLQ-C30 and PRO-CTCAE), economic evaluation (EQ-5D-5L). TERTIARY: compare PFS in two treatment arms based on PIK3CA/AKT1/PTEN altered status as determined using archival tissue, identification of prognostic biomarkers, creation of a biobank of FFPE, cfDNA, and digital images, characterize pharmacokinetics

Participation: Limited to invited centres

Lay Description: A trial comparing ipatasertib and fulvestrant with placebo and fulvestrant in patients with ER positive, HER-2 negative advanced breast cancer.

Primary Publication Show

Other Publications Show

Inventory
Hide Tissue Samples

Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
BREAST	MA40	Open Trial	81	101	178

Hide TMA Samples

(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
BREAST	MA40	Open Trial	0	0

Hide Fluid Samples

Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
BREAST	MA40	Open Trial	187	0	0	0	205	0	0	0