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Estrogen Receptor Antagonist
Inavolisib Combination for Breast Cancer (INAVO120 Trial)
Phase 2 & 3
Waitlist Available
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)
Metastatic or locally advanced disease not amenable to curative therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
INAVO120 Trial Summary
This trial will study whether adding inavolisib to palbociclib and fulvestrant improves outcomes for women with PIK3CA-mutant, hormone receptor-positive, HER2-negative breast cancer that has progressed after endocrine therapy.
Who is the study for?
This trial is for adults with a specific mutation in their breast cancer cells (PIK3CA), whose cancer has worsened during or after hormone therapy and haven't had treatment for advanced disease. They must have measurable disease, provide tissue samples, have good organ function, not be pregnant or breastfeeding, and can't have untreated brain metastases or prior treatments that are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of Inavolisib combined with Palbociclib and Fulvestrant versus a placebo plus Palbociclib and Fulvestrant in treating certain advanced breast cancers. It aims to see if adding Inavolisib helps patients better than the standard treatment alone.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver issues indicated by abnormal blood tests, eye inflammation or infections requiring surgery.
INAVO120 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a specific genetic change in the PIK3CA gene.
Select...
My cancer has spread and cannot be cured with surgery or radiation.
Select...
My breast cancer is hormone receptor positive and HER2 negative.
Select...
I am fully active or can carry out light work.
INAVO120 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Best Overall Response Rate (BOR)
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
+10 moreINAVO120 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inavolisib + Palbociclib + FulvestrantExperimental Treatment3 Interventions
Participants will receive inavolisib, palbociclib, and fulvestrant.
Group II: Placebo + Palbociclib + FulvestrantPlacebo Group3 Interventions
Participants will receive placebo, palbociclib, and fulvestrant.
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
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,729 Total Patients Enrolled
159 Trials studying Breast Cancer
91,142 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,177 Total Patients Enrolled
137 Trials studying Breast Cancer
71,771 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken fulvestrant or similar drugs for more than 6 months, except as part of early treatment.I do not have active eye infections or conditions needing surgery soon.I have not had major surgery or a significant injury in the last 28 days.My cancer has a specific genetic change in the PIK3CA gene.You are expected to live for more than 6 months.I am on long-term steroids or drugs that suppress my immune system.My cancer can be measured by scans and is not limited to only my bones.My breast cancer is of a rare type called metaplastic.My cancer progressed during or within 12 months after hormone therapy.I have not had cancer treatment in the last 2 weeks.I have been on LHRH agonist therapy for at least 2 weeks if I am pre or peri-menopausal.My cancer has spread and cannot be cured with surgery or radiation.I have a history of inflammatory bowel disease or currently have active bowel inflammation.I have Type 2 diabetes and am on treatment, or I have a history of Type 1 diabetes.I have not taken drugs targeting the PI3K-AKT-mTOR pathway.I have received treatment for breast cancer that has spread.I have brain metastases that are either untreated or currently active.My blood and organs are functioning well enough for treatment.I have had leptomeningeal disease or carcinomatous meningitis.I need daily oxygen or have symptoms from lung disease.My breast cancer is hormone receptor positive and HER2 negative.I am fully active or can carry out light work.I have had significant radiation therapy or a bone marrow transplant.I haven't taken any experimental drugs in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + Palbociclib + Fulvestrant
- Group 2: Inavolisib + Palbociclib + Fulvestrant
Awards:
This trial has 0 awards, including: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.
What are the conditions that Inavolisib is approved to target?
"cancers like malignant neoplasms, as well as conditions resulting from a pik3ca gene mutation, can be treated by Inavolisib."
Answered by AI
What is the general efficacy of Inavolisib?
"Inavolisib was first studied in the year 2004 at Lowell General Hospital. So far there have been 18386 completed studies. There are presently 246 actively recruiting clinical trials, with many of these studies running out of Paris, Texas."
Answered by AI
How many hospitals are conducting this research?
"Right now, this trial is enrolling patients at 27 different sites. If you are considering participating, please choose the location nearest to you from the list of 27 sites, which includes Paris, Saint Petersburg and Dallas."
Answered by AI
Are there any current openings for patients who wish to enroll in this study?
"That is accurate. The clinical trial was initially posted on 1/29/2020 and was most recently updated on 10/7/2022. The study is recruiting for 400 patients between 27 sites."
Answered by AI
How effective has this trial been in recruiting patients?
"400 individuals that meet the prerequisites for this study need to enroll. These patients can come from different trial sites, such as Texas Oncology - Northeast Texas in Paris, Texas and Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) in Saint Petersburg, Florida."
Answered by AI
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