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Protein Kinase Inhibitor

Palbociclib + Fulvestrant + Ipatasertib (Interventional arm) for Breast Cancer (FAIM Trial)

Phase 2

Recruiting

Led By Alicia Okines

Research Sponsored by Royal Marsden NHS Foundation Trust

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 38 months

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

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.

Eligible Conditions

Breast Cancer
Breast cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 38 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 38 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 38 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess progression free survival (PFS)

Secondary study objectives

Assess objective response rate

Assess overall survival

Breast

+2 more

Other study objectives

Compare progression free survival (PFS) in patients with high ctDNA at C1D15 and genetic alterations identified in ctDNA sequencing.

Evaluate changes in ctDNA in patients with high ctDNA C1D15

Report progression free survival (PFS) in patients with undetectable ctDNA and those with detected ctDNA at C1D1 with and without suppression at C1D15.

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Palbociclib + Fulvestrant + Ipatasertib (Interventional arm)Experimental Treatment3 Interventions

Where high ctDNA is detected in screening, patients to be randomised on a 1:1 basis to interventional arm or comparison arm. Patients randomised to interventional arm receive Palbociclib + Fulvestrant + Ipatasertib. n = 87.

Group II: Palbociclib + Fulvestrant (Comparison arm)Active Control2 Interventions

Where high ctDNA is detected in screening, patients to be randomised on a 1:1 basis to interventional arm or comparison arm. Patients randomised to Comparison arm receive Palbociclib + Fulvestrant. n = 87.

Group III: Standard of Care (No ctDNA observational arm)Active Control2 Interventions

Where no ctDNA is detected in screening, patients to be allocated to the observational arm and receive standard of care (Abemaciclib / Ribociclib / Palbociclib + fulvestrant). n = 50.

Group IV: Standard of Care (Low ctDNA observational arm)Active Control2 Interventions

Where low ctDNA is detected in screening, patients to be allocated to the observational arm and receive standard of care (Abemaciclib / Ribociclib / Palbociclib + fulvestrant). n = 100.

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