NCT04920708 - Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression | Biotech Hunter

Enrollment

324

Participants

Timeline

Start Date

December 28, 2022

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions

Metastatic Breast CancerER+ Breast CancerAdvanced Breast Cancer

Interventions

DRUG

Ipatasertib 300mg

Ipatasertib 300mg once daily. Oral administration. Treatment is continuous daily for 21 days, followed by 7 days off, to complete a 28 day cycle.

DRUG

Fulvestrant 500g

Fulvestrant 500mg administered intramuscularly in the buttocks slowly (1-2 minutes per injection) as two 5-mL injections (one in each buttock). Administered days 1 and 15 of Cycle 1. For subsequent cycles, patients will receive fulvestrant as described above in the clinic on Day 1 of each cycle or approximately every 4 weeks.

DRUG

Palbociclib 75mg-125mg

Palboclicib 75mg-125mg once daily, dependent on toxicities. Oral administration. Treatment is continuous daily for 21 days, followed by 7 days off, to complete a 28 day cycle.

DRUG

CDK4/6 Inhibitor

CDK4/6 inhibitor. As per current standard of care regime for ER+/HER2- breast cancer.

Trial Locations (18)

CB2 0QQ

RECRUITING

The Christie NHS Foundation Trust, Manchester