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

NCT04920708 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Alicia Okines · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-28
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04920708 on ClinicalTrials.gov