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Monoclonal Antibodies
Inavolisib + Phesgo for Breast Cancer
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 111 months
Awards & highlights
Study Summary
This trial will test a new treatment for HER2+ advanced breast cancer, looking at effectiveness and safety.
Who is the study for?
This trial is for adults with HER2-positive advanced breast cancer that hasn't been treated yet. They should have a certain gene mutation (PIK3CA), good heart function, and no diabetes requiring systemic treatment. People who've had specific eye conditions, severe liver disease, lung problems like pneumonitis, or inflammatory bowel disease can't join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Inavolisib combined with Phesgo against a placebo with Phesgo after initial therapy. It's for those whose breast cancer has spread or can't be surgically removed.See study design
What are the potential side effects?
Possible side effects include reactions to the drug infusion, changes in blood counts affecting organ functions, potential worsening of diabetes if present, eye inflammation risks, and possible exacerbation of liver or lung conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 111 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 111 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator-Assessed Progression-Free Survival (PFS)
Secondary outcome measures
Investigator-Assessed Clinical Benefit Rate (CBR)
Investigator-Assessed Duration of Response (DOR)
Investigator-Assessed Objective Response Rate (ORR)
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance Therapy: Inavolisib plus PhesgoExperimental Treatment3 Interventions
Participants will be administered the treatments as outlined in the interventions section.
Group II: Induction Therapy: Phesgo plus Taxane-Based ChemotherapyExperimental Treatment2 Interventions
Participants will be administered the treatments as outlined in the interventions section.
Group III: Maintenance Therapy: Placebo plus PhesgoActive Control3 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
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,993 Total Patients Enrolled
160 Trials studying Breast Cancer
91,442 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,710 Total Patients Enrolled
138 Trials studying Breast Cancer
72,096 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatments for advanced HER2-positive breast cancer before starting the current therapy.My cancer is confirmed HER2 positive by a specialized lab test.My cancer has a PIK3CA mutation according to a specialized test.I have or had inflammatory bowel disease.I have Type 2 diabetes and am on treatment, or I have a history of Type 1 diabetes.I have not been treated with drugs targeting the PI3K-AKT-mTOR pathway for advanced cancer.I am fully active or can carry out light work.I have lung problems like pneumonitis or interstitial lung disease.My cancer worsened within 6 months after starting HER2 therapy.My blood and organs are functioning well enough to start treatment.I have had eye inflammation or infections, or a history of uveitis.I have never had cancer spread to the lining of my brain or spinal cord.I don't have any eye conditions needing treatment that could affect my vision during the study.My cancer returned 6 months or more after completing initial treatment.I haven't needed IV antibiotics for a serious infection in the last 7 days.I do not have severe liver problems, hepatitis, alcohol abuse, or cirrhosis.My breast cancer is advanced and cannot be removed with surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Maintenance Therapy: Inavolisib plus Phesgo
- Group 2: Induction Therapy: Phesgo plus Taxane-Based Chemotherapy
- Group 3: Maintenance Therapy: Placebo plus Phesgo
Awards:
This trial has 1 awards, including:- 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.
Does this research team need any additional volunteers at present?
"Affirmative. The clinical information hosted on clinicaltrials.gov verifies that this experiment is still accepting patients, having been posted on July 1st 2023 and updated as recently as June 21st 2023. 230 individuals are required for the trial at two medical centres."
Answered by AI
To date, what is the highest number of individuals who have taken part in this medical research?
"Affirmative. Data on clinicaltrials.gov demonstrates that this medical experiment, initially posted on July 1st 2023, is currently enlisting volunteers. Approximately 230 test subjects need to be recruited from 2 separate locations."
Answered by AI
What level of risk is associated with using the Maintenance Therapy: Inavolisib plus Phesgo combination?
"Our team at Power assesses the safety of Maintenance Therapy: Inavolisib plus Phesgo with a score of 3, due to multiple rounds of evidence confirming efficacy and prior data suggesting its security."
Answered by AI
Who else is applying?
What site did they apply to?
Banner Health MD Anderson AZ
What portion of applicants met pre-screening criteria?
Did not meet criteria
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