Study on Gedatolisib and Talazoparib for Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers
Sponsor: Kari Wisinski
ClinicalTrials ID:NCT03911973
This clinical trial is testing a new combination of drugs, gedatolisib and talazoparib, to see if they are safe and effective in treating advanced breast cancer that is either triple negative or has BRCA1/2 mutations and is HER2 negative.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find the best dose of gedatolisib when used with talazoparib and to see how well this combination works in treating advanced breast cancer that is HER2 negative and either triple negative or has BRCA1/2 mutations. Triple negative breast cancer lacks certain receptors, making it harder to treat, and often requires chemotherapy. This trial explores a new treatment option that doesn't rely on chemotherapy, potentially offering better outcomes for patients with these types of breast cancer.
Description
Triple negative breast cancer (TNBC) is a type of breast cancer that does not have hormone receptors or the HER2 protein, making it difficult to treat. It accounts for about 15% of all breast cancer cases in the U.S. and has a lower survival rate compared to other types. Some breast cancers have genetic mutations in BRCA1 or BRCA2, which affect DNA repair and are often triple negative.
PARP inhibitors, like talazoparib, help block DNA repair in cancer cells, especially those with BRCA mutations, making them a promising treatment. Gedatolisib is another drug that targets cancer cell growth pathways and has been shown to be safe in previous studies. This trial combines gedatolisib with talazoparib to see if they can work together to treat advanced breast cancer more effectively than current options.
The study will determine the best dose of gedatolisib to use with talazoparib and evaluate how well this combination works in patients with advanced HER2 negative breast cancer that is either triple negative or has BRCA1/2 mutations.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with advanced breast cancer that is either metastatic or cannot be surgically removed.
- For Phase II Cohort A: Patients with advanced triple negative breast cancer with negative or unknown BRCA status.
- For Phase I run-in: Patients must meet criteria for either Cohort A or B.
- Must have measurable disease as defined by specific criteria.
- Must have had at least one prior treatment for advanced breast cancer.
- No prior use of PARP inhibitors for advanced breast cancer.
- Good overall health with a performance status score of 0, 1, or 2.
- Life expectancy of at least 12 weeks.
- Adequate organ function based on lab tests.
- Ability to take oral medications.
- No history of type I diabetes; controlled type II diabetes is allowed.
- No active brain metastases; any previous brain involvement must be treated and stable.
- Must provide written informed consent and agree to study procedures.
- Women of childbearing potential must not be pregnant or breastfeeding and must use effective birth control during and after the study.
- Men must agree to use contraception if their partners are of childbearing potential.
Exclusion Criteria
- Active infection requiring treatment.
- Pregnant or breastfeeding women.
- Recent chemotherapy, targeted therapy, or radiotherapy within 2 weeks before the study.
- Recent use of investigational drugs within 14 days before the study.
- Recent major surgery within 14 days before the study.
- Other cancers that could interfere with the study.
- Allergies to study drugs.
- Gastrointestinal issues affecting drug absorption.
- Active hepatitis B or C.
- History of certain blood disorders.
- Recent lung inflammation or significant lung disease.
- Recent heart issues or severe heart conditions.
- Severe uncontrolled medical conditions.
- Use of certain blood thinners not allowed.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern University Feinberg School of Medicine | 60611 | Chicago | Illinois |
| University of Illinois Cancer Center | 60612 | Chicago | Illinois |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | 46202 | Indianapolis | Indiana |
| University of Iowa Hospital and Clinics | 52242 | Iowa City | Iowa |
| University of Wisconsin | 53792 | Madison | Wisconsin |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.