LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04032080|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2019
Last Update Posted : July 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Combination Product: Drug 1: LY3023414; Drug 2: Prexasertib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression.|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||September 5, 2019|
|Actual Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: LY3023414 + prexasertib
Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression. Patients whose disease does not respond to the combination of LY3023414 and prexasertib may be treated with standard of care breast cancer therapies off study, at the recommendation of the treating physician.
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.
- Efficacy (objective response rate) [ Time Frame: Through study completion, 18 months ]To assess the objective response rate (CR+PR) associated with LY3023414 and prexasertib in metastatic TNBC patients.
- Efficacy (duration of response) [ Time Frame: through study completion, 18 months] ]To assess duration of response to combination of LY3023414 and prexasertib in metastatic TNBC patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032080
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Joyce A O'Shaughnessy, MD||Baylor Scott and White University Medical Center|