NCT04032080

LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Seventy to eighty percent of breast cancers have a gene expression profile which is characterized by homologous recombination deficiency (HRD) and high proliferation. HRD leads to errors in DNA pathway \[non -homologous end joining (NHEJ)\] that repair DNA-breaks, a process required for metastatic triple negative breast cancer (TNBC) survival. The hypothesis of this pilot trial is that administration of LY3023414 and prexasertib will inhibit NHEJ in metastatic TNBC.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2019-09-05
• Primary completion: 2022-06-01
• Completion: 2022-11-26
• First posted: 2019-07-25
• Last updated: 2023-09-11
• Results posted: 2023-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study