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Trial Summary

Protocol No.CTO-BTCRC-BRE18-337
Principal InvestigatorMiller, Kathy
PhasePhase I/II
Age GroupAdult
TitlePhase 2 Trial with Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers Big Ten Cancer Research Consortium BTCRC-BRE18-337
DescriptionThis 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).
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Male or female greater than/equal to 18 years of age at time of consent.
  • Subjects with histologically or confirmed breast cancer that is advanced (defined as metastatic or unresectable).
  • No history of type I diabetes. For patients with known type II diabetes, must have controlled diabetes (Hgb A1c < 7.0 mmol/L within 30 days of study entry) with no more than one oral anti-diabetic agent and no insulin.
For a full list of participation criteria, please visit
Applicable Disease SitesBreast
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632