Study of inavolisib, palbociclib and letrozole combination for patients with advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation
This study focuses on advanced breast cancer that is hormone receptor-positive, HER2-negative, and has a specific genetic change called PIK3CA mutation. The research evaluates a combination treatment that includes three medications: inavolisib (also known as GDC-0077), letrozole, and a type of drug called a CDK4/6 inhibitor (palbociclib). Some participants will receive these active medications, while others will receive a placebo instead of inavolisib, along with the other treatments.
The main purpose is to determine how well the combination of inavolisib with letrozole and palbociclib works compared to using just letrozole and palbociclib with a placebo in treating this specific type of breast cancer. The study will measure how long participants remain without their cancer getting worse while receiving the treatment.
All medications in this study are taken by mouth in the form of tablets. The study will track various aspects of participants’ health, including how well the treatment works, any side effects that may occur, and how the treatment affects their quality of life. This research is planned as a long-term study that will continue for several years to gather comprehensive information about the effectiveness and safety of this treatment combination.
1Initial assessment
Your eligibility for the study will be confirmed through blood tests or existing tumor tissue analysis to check for PIK3CA mutation
Medical evaluation will be performed to verify measurable disease using RECIST criteria (a standardized way to measure tumors)
Laboratory tests will be conducted to check blood counts and organ function
2Treatment assignment
You will be randomly assigned to one of two treatment groups
Group 1: Inavolisib + CDK4/6 inhibitor (Palbociclib) + Letrozole
Group 2: Placebo + CDK4/6 inhibitor (Palbociclib) + Letrozole
3Treatment administration
All medications will be taken by mouth in tablet form
If you are premenopausal or a male patient, you will also receive hormone therapy (LHRH agonist)
Regular assessments will monitor your tumor response to treatment
4Monitoring and evaluation
Regular checks of vital signs and laboratory tests
Assessment of any side effects using standardized criteria
Completion of quality of life questionnaires about pain, physical function, and treatment side effects
Regular imaging to measure tumor response
5Follow-up period
Continued monitoring until disease progression or other stopping criteria are met
Assessment of long-term treatment effects
Documentation of any side effects or health changes
Who Can Join the Study?
You must have hormone receptor-positive (HR+) and HER2-negative advanced breast cancer that is either:
Newly diagnosed, or
Returned after at least 2 years of standard hormone therapy treatment
If you previously received CDK4/6 inhibitor treatment (a type of targeted therapy), your cancer must not have progressed during treatment or within 1 year after stopping it
You must have a confirmed PIK3CA mutation (a specific genetic change) in your blood or tumor tissue through testing
Your cancer must be measurable using standard imaging criteria (RECIST v1.1)
You can be:
A man of any age
A woman who has gone through menopause
A woman who has not gone through menopause or is going through menopause
If you are a man or a woman who has not completed menopause, you must be willing to receive hormone-blocking therapy (LHRH agonist) throughout the study
Your blood tests and organ function tests must show acceptable results within 14 days before starting the study treatment
Who Cannot Join the Study?
Prior treatment with a PI3K inhibitor (a type of targeted cancer therapy)
Active brain metastases (cancer that has spread to the brain) or spinal cord compression
History of diabetes requiring insulin treatment
Severe heart conditions, including:
Unstable angina (chest pain)
Heart attack within the past 6 months
Uncontrolled high blood pressure
Significant liver problems or active hepatitis B or C infection
Known allergic reactions to similar medications
Pregnant or breastfeeding women
Any other serious medical condition that could affect study participation
Current participation in another clinical trial
Unable to swallow oral medications
History of other cancers within the past 5 years (except adequately treated non-melanoma skin cancer or cervical cancer in situ)
Inavolisib is a medication that targets specific mutations in breast cancer cells, particularly those with PIK3CA mutations. It works by blocking certain proteins that can contribute to cancer growth. This medication is being studied as a new treatment option for advanced breast cancer.
Letrozole is a hormone therapy medication that works by reducing the amount of estrogen produced in the body. It is commonly used to treat hormone receptor-positive breast cancer in postmenopausal women.
CDK4/6 inhibitor is a type of targeted therapy that blocks specific proteins called CDK4 and CDK6, which help control cell growth. These medications help slow down or stop the growth of cancer cells and are already approved for treating certain types of breast cancer.
PIK3CA-Mutated Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer – A specific type of breast cancer characterized by mutations in the PIK3CA gene and the presence of hormone receptors, while lacking HER2 protein overexpression. This cancer develops when breast cells acquire specific genetic changes in the PIK3CA gene, which affects cell growth and division. The cancer cells in this type respond to hormones like estrogen and progesterone but do not have excessive amounts of HER2 protein on their surface. This form of breast cancer typically grows and spreads more slowly than some other types. The disease can spread beyond the breast to other parts of the body, while maintaining its original characteristics.
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