Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor

Official Title

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

Summary:

The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).

Trial Description

Primary Outcome:

• Progression-free survival (PFS) using RECIST 1.1

Secondary Outcome:

• To compare the two treatment arms with respect to investigator assessed PFS (per RECIST 1.1) in the PIK3CA/AKT1/PTEN altered cohort
• Investigator assessed PFS (per RECIST 1.1) in the PIK3CA/AKT1/PTEN non-altered cohort
• PFS as assessed by blinded central radiology review in all enrolled patients, PIK3CA/AKT1/PTEN altered and non-altered cohorts
• Response rate (RR) (per RECIST 1.1)
• Duration of Response (DoR)
• Clinical Benefit Rate (CBR);
• Overall survival (OS)
• Time to commencement of subsequent line of systemic therapy or death (TSST)
• Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
• Quality of Life (QOL) as measured using EORTC QLQ-C30 questionnaire
• Adverse events as measured using NCI PRO-CTCAE questionnaire
• Economic Evaluation of healthcare utilization using average cost per study subject by treatment arm to estimate an overall mean cost per study arm.
• Economic Evaluation of health utilities measured using EQ-5D-5L

Patients enrolled in this study will receive either Ipatasertib plus Fulvestrant or placebo (a substance that looks like the study drug but does not have any active or medicinal ingredient) plus Fulvestant. The study will provide information about the ability of Ipatasertib plus Fulvestrant to control the cancer, the side effects and safety of the treatment, how patients feel while taking the treatment and associated costs.

View this trial on ClinicalTrials.gov