CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Drug 1: LY3023414; Drug 2: Prexasertibcombination
Likely dose
Drug 1: LY3023414; Drug 2: Prexasertib 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04032080
NCT04032080Phase 2Completed

Pilot Clinical Trial of Treatment With LY3023414 and Prexasertib to Inhibit Homologous Recombination (HR) in Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer (Amendment 1)

Baylor Research Institute·interventional·Posted Jul 25, 2019·Updated Sep 11, 2023

In Brief

A Phase 2 clinical trial evaluating Drug 1: LY3023414; Drug 2: Prexasertib for Triple Negative Breast Cancer. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This study evaluates efficacy of LY3023414 and prexasertib in patients with metastatic triple negative breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 25, 2019
Enrollment StartSep 5, 2019
Primary CompletionJun 1, 2022
Study CompletionNov 26, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.9 years ago

Interventions

Drug 1: LY3023414; Drug 2: Prexasertibcombination

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.