10
Participants
Start Date
September 5, 2019
Primary Completion Date
June 1, 2022
Study Completion Date
November 26, 2022
Drug 1: LY3023414; Drug 2: Prexasertib
"Metastatic TNBC patients will consent to and undergo core needle biopsies of a metastatic lesion for NGS, RPPA, and other molecular analyses at study entry.~Patients will then be treated with 150 mg LY3023414 PO BID and prexasertib 80 mg/m\^2 IV administered every 2 weeks until disease progression or unacceptable toxicity. Any time after the completion of Cycle 2 of the treatment combination, or at the physician's discretion, a second core needle biopsy of the same metastatic lesion (or different metastases if the initial metastasis has regressed) will be performed for RPPA and other molecular analyses. If a research biopsy from a patient's metastatic disease cannot be safely obtained, a skin biopsy is permitted.~Treatment will be discontinued in patients who achieve a confirmed clinical complete response, and these patients will be followed to document the durability of the complete responses."
Baylor University Medical Center, Dallas
Lead Sponsor
Eli Lilly and Company
INDUSTRY
Baylor Research Institute
OTHER