NCT04650581

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Ipatasertib	400 mg PO QD days 1-21 every 28 days
DRUG	Fulvestrant	500 mg IM cycle 1 days 1 and 15 followed by 500 mg IM day 1 q 28 days subsequent cycles
OTHER	Placebo	PO QD days 1-21 every 28 days

Timeline

• Start date: 2021-01-27
• Primary completion: 2025-05-23
• Completion: 2026-12-31
• First posted: 2020-12-02
• Last updated: 2026-04-13
• Results posted: 2026-01-28

Locations

39 sites across 3 countries: Australia, Canada, New Zealand