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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
Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
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 belowSelect...
My cancer has a specific PIK3CA mutation.
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I can take care of myself and am up and about more than half of my waking hours.
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My breast cancer is advanced and cannot be removed by surgery or cured with radiation.
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My breast cancer is hormone-receptor positive and HER2-negative.
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My recommended treatment is hormone therapy, not chemotherapy.
INAVO121 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until death due to any cause (up to approximately 85 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death due to any cause (up to approximately 85 months)
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 moreINAVO121 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
2,431 Previous Clinical Trials
1,089,668 Total Patients Enrolled
159 Trials studying Breast Cancer
91,042 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,540 Total Patients Enrolled
137 Trials studying Breast Cancer
71,696 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had leptomeningeal disease or carcinomatous meningitis.You are expected to live for more than 6 months.I have Type 2 diabetes and am on treatment, or I have a history of Type 1 diabetes.My cancer returned more than a year after completing CDK4/6 inhibitor therapy, with no treatment for its spread.I do not have conditions that affect how my body absorbs food.My blood and organs are functioning well enough to start treatment.I am currently suffering from jawbone decay.I haven't taken any experimental drugs recently.I cannot or do not want to swallow pills.I am not allergic to inavolisib, fulvestrant, or alpelisib.My breast cancer progressed after treatment with CDK4/6 inhibitors and hormone therapy, with no more than 2 treatments in the metastatic setting.You have a known HIV infection that meets certain criteria.I do not have an active infection or have been hospitalized for one in the last week.You have a tumor that can be measured or evaluated using specific guidelines for assessing tumor response.You have had serious skin reactions such as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis in the past.My cancer has a specific PIK3CA mutation.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.I do not have severe liver problems, hepatitis, alcohol abuse, or cirrhosis.I have previously been treated with drugs targeting the PI3K/AKT/mTOR pathway for advanced cancer.I currently have active bowel inflammation.I have brain metastases that are either untreated or currently active.I can take care of myself and am up and about more than half of my waking hours.My breast cancer is advanced and cannot be removed by surgery or cured with radiation.I have symptoms of lung problems, like trouble breathing.I take 10 mg or more of prednisone daily for a chronic condition.My breast cancer is hormone-receptor positive and HER2-negative.I have had eye inflammation or infections, or a history of uveitis related to autoimmune disease.I need extra oxygen every day.I have or had inflammatory bowel disease.I haven't had any cancer except low-risk ones in the last 5 years.My breast cancer is of a rare type called metaplastic.I don't have any eye conditions needing treatment that could affect my vision during the study.My recommended treatment is hormone therapy, not chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Inavolisib + Fulvestrant
- Group 2: Alpelisib + Fulvestrant
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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