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PI3K Inhibitor

Inavolisib + Fulvestrant vs Alpelisib + Fulvestrant for Breast Cancer (INAVO121 Trial)

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed
Adequate hematologic and organ function prior to initiation of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until death due to any cause (up to approximately 85 months)
Awards & highlights

INAVO121 Trial Summary

This trial compares two treatments for HR+/HER2-/PIK3CA-mutated mBC that failed CDK4/6i-based therapy.

Who is the study for?
This trial is for adults with HR-positive, HER2-negative, PIK3CA mutated advanced or metastatic breast cancer who've progressed after CDK4/6i and endocrine therapy. They should have a life expectancy over 6 months, an ECOG status of 0-2, and no more than two prior systemic therapies in the metastatic setting (one chemo allowed). Pre/perimenopausal women must be on LHRH agonist therapy.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of Inavolisib plus Fulvestrant versus Alpelisib plus Fulvestrant in patients whose breast cancer has worsened despite previous treatments. It's a Phase III trial where participants are randomly assigned to one of these treatment combinations.See study design
What are the potential side effects?
Potential side effects include digestive issues, liver problems, blood sugar changes (especially important for diabetics), skin reactions like rashes or severe conditions such as Stevens-Johnson Syndrome, inflammation or infection risks including pneumonitis and eye inflammation.

INAVO121 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer progressed after treatment with CDK4/6 inhibitors and hormone therapy, with no more than 2 treatments in the metastatic setting.
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My blood and organs are functioning well enough to start treatment.
Select...
My cancer has a specific PIK3CA mutation.
Select...
I started hormone therapy at least 2 weeks ago if I'm a woman who has not gone through menopause or I'm a man.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My breast cancer is advanced and cannot be removed by surgery or cured with radiation.
Select...
My breast cancer is hormone-receptor positive and HER2-negative.
Select...
My recommended treatment is hormone therapy, not chemotherapy.

INAVO121 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death due to any cause (up to approximately 85 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death due to any cause (up to approximately 85 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)
Secondary outcome measures
BICR-Assessed Best Overall Response (BOR)
BICR-Assessed Clinical Benefit Rate (CBR)
BICR-Assessed Duration of Response (DOR)
+8 more

INAVO121 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Inavolisib + FulvestrantExperimental Treatment2 Interventions
Participants will be administered the treatments as outlined in the interventions section.
Group II: Alpelisib + FulvestrantActive Control2 Interventions
Participants will be administered the treatments as outlined in the interventions section.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inavolisib
2021
Completed Phase 2
~260
Fulvestrant
2011
Completed Phase 3
~3690

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,654 Total Patients Enrolled
159 Trials studying Breast Cancer
91,067 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,102 Total Patients Enrolled
137 Trials studying Breast Cancer
71,696 Patients Enrolled for Breast Cancer

Media Library

Alpelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05646862 — Phase 3
Breast Cancer Research Study Groups: Inavolisib + Fulvestrant, Alpelisib + Fulvestrant
Breast Cancer Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT05646862 — Phase 3
Alpelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05646862 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to join this experiment at present?

"As indicated on clinicaltrials.gov, this trial is actively looking for participants and was recently updated on February 17th 2023; the initial posting date being March 17th 2023."

Answered by AI

Has the FDA granted sanction to Inavolisib + Fulvestrant?

"Our analysis at Power ranked the safety of Inavolisib + Fulvestrant as a 3 due to its Phase 3 status, meaning there is substantial evidence demonstrating both efficacy and safety."

Answered by AI

How extensive is the participant base in this trial?

"Affirmative. According to the clinicaltrials.gov website, this trial is actively accepting patients and was published on March 17th 2023. The study seeks 400 participants at a single location - its most recent edit being February 17th 2023."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Lumi Research
~267 spots leftby Mar 2029