Gedatolisib + Talazoparib for Breast Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen ByKari Wisinski, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Kari Wisinski

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is designed to determine the RP2D of gedatolisib in combination with talazoparib and to evaluate the efficacy of this combination in advanced HER2 negative breast cancer that is triple negative or BRCA1/2 positive (deficient).

Eligibility Criteria

This trial is for adults with advanced HER2 negative breast cancer that's either triple negative or BRCA1/2 positive. Participants must have measurable disease, be able to take oral meds, and not be pregnant or breastfeeding. They should agree to use contraception if necessary and have no major health issues like diabetes, active infections, or a history of certain heart conditions.

Inclusion Criteria

I have stored samples of my tumor.

My breast cancer is confirmed and advanced.

I do not have cancer that has spread to my brain or spinal cord.

I am not pregnant or breastfeeding.

I am willing to use two effective birth control methods.

I am a man who can father children and will use birth control.

I have advanced triple negative breast cancer without known BRCA gene mutations.

I do not have a history of type I diabetes.

Exclusion Criteria

I don't have any other cancer that could affect this treatment's safety or results.

I am currently on medication for an infection.

I have a history of myelodysplastic syndrome or acute myeloid leukemia.

I am currently taking warfarin or a similar blood thinner.

I have no GI conditions that affect medication absorption.

I have not had major surgery in the last 14 days.

I do not have a history of severe lung, heart, brain, or uncontrolled medical conditions.

Participant Groups

The study tests the combination of gedatolisib plus talazoparib in treating advanced breast cancer. It aims to find the right dose and assess how effective this combo is against specific types of breast cancer that lack three common receptors (triple-negative) or carry BRCA mutations.

1Treatment groups

Experimental Treatment

Group I: Talazoparib + GedatolisibExperimental Treatment2 Interventions

Talazoparib + Gedatolisib Phase 1: Dose Level -1: Gedatolisib 150mg IV, Days 1,8,15,22; Talazoparib 0.75 mg/orally qd, Days 1-28 Dose Level 1: Gedatolisib 180mg IV, Days 1,8,15,22; Talazoparib 0.75 mg/orally qd, Days 1-28 Dose Level 2: Gedatolisib 180mg IV, Days 1,8,15,22; Talazoparib 1.00 mg/orally qd, Days 1-28 Phase 2: Gedatolisib 180 mg IV on days 1, 8, 15 and 22; Talazoparib 1.00 mg once daily, Days 1-28. Subjects receiving weekly gedatolisib may continue current regimen or may switch to gedatolisib 180 mg IV on days 1, 8, and 15; Talazoparib 1.00 mg once daily, Days 1-28 (3 weeks on/ 1 week off). All changes will be permanent.