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LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

NCT04032080•Baylor Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients ≥18 years of age. Patients must agree to use one highly effective (less than 1% failure rate) method of contraception or use a combination of two effective methods of contraception during treatment with study drug and for at least 12 weeks following the last dose of study drug.
•2. Have a diagnosis of metastatic TNBC previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy, unless there was a contraindication to doxorubicin, in which case prior treatment with this agent is not required. NOTE: TNBC defined as ER-negative tumors with ≤10% tumor nuclei immunoreactivity, or "ER Low Positive" as defined by the updated ASCO/CAP guidelines 2020.
•3. Have not received more than 3 prior chemotherapy regimens for metastatic disease. Prior platinum and/or taxane therapy in the adjuvant or metastatic setting is permitted.
•4. Have locoregional (eg, breast, chest wall, regional lymphatic) or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy. If a research biopsy from a patient's metastatic disease cannot be safely obtained, a skin biopsy is permitted. If a skin biopsy cannot be safely obtained, patients may still be eligible, per physician discretion.
•5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•6. Have adequate hematologic function, defined by:
•1. Absolute neutrophil count (ANC) \>1500/mm\^3
•2. Platelet count ≥100,000/mm\^3
•3. Hemoglobin ≥9 g/dL
•7. Have adequate liver function, defined by:
+23 more criteria

Exclusion Criteria

•1. Have a family history of long QT Syndrome and serious cardiac conditions.
•2. Have QTcF interval of \>470 msec on screening electrocardiogram (ECG) as well as on pre-dose Cycle 1 Day 1 ECG

Locations (1)

Baylor University Medical Center

Dallas, Texas, United States

Key Dates

Start Date

September 5, 2019

Primary Completion Date

June 1, 2022

Completion Date

November 26, 2022

Last Updated

September 11, 2023

Enrollment

ACTUAL participants

Conditions

Triple Negative Breast Cancer

Interventions

Drug 1: LY3023414; Drug 2: Prexasertib

COMBINATION_PRODUCT

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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RECRUITINGPHASE1

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

NCT07029399

HR+ Breast CancerTriple Negative Breast Cancer (TNBC)+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer

A Study of LY4175408 in Participants With Advanced Cancer