LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer

  • STATUS
    Recruiting
  • days left to enroll
    79
  • participants needed
    10
  • sponsor
    Baylor Research Institute
Updated on 12 February 2022
platelet count
cancer
cyclophosphamide
breast cancer
doxorubicin
anthracyclines
metastasis
neutrophil count
brain metastases
chemotherapy regimen
triple negative breast cancer
taxane
mammogram
core needle biopsy
renal function test

Summary

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

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.

Details
Condition Triple Negative Breast Cancer
Treatment Drug 1: LY3023414; Drug 2: Prexasertib
Clinical Study IdentifierNCT04032080
SponsorBaylor Research Institute
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
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
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
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Have adequate hematologic function, defined by
Absolute neutrophil count (ANC) >1500/mm^3
Platelet count 100,000/mm^3
Hemoglobin 9 g/dL
Have adequate liver function, defined by
AST and ALT 2.5 x the upper limit of normal (ULN) or 5 x ULN in presence of liver metastases
Total bilirubin 1.5 x ULN
Have adequate renal function, defined by
Serum creatinine 1.5 x ULN or calculated creatinine clearance of 60 ml/min
Have the ability to swallow oral medications
Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met
Brain metastases which have been treated
Off-treatment with steroids for 2 weeks before administration of the first dose of LY3023414 and prexasertib
No ongoing requirement for dexamethasone or anti-epileptic drugs
No clinical or radiological evidence of progression of brain metastases
Patient must be accessible for treatment and follow-up
All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry

Exclusion Criteria

Have a family history of long QT Syndrome and serious cardiac conditions
Have QTcF interval of >470 msec on screening electrocardiogram (ECG) as well as on pre-dose Cycle 1 Day 1 ECG
Have insulin-dependent diabetes mellitus. Patients with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by HbA1c <8%. Patients with type 1 diabetes mellitus are not eligible
Previous radiotherapy for metastatic disease completed <2 weeks prior to study treatment initiation
Women who are pregnant or lactating
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as
severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)
viral hepatitis or HIV
Concurrent use of CYP3A4 inhibitors and inducers from 72 hours prior to initiation of study treatment until the end of treatment
History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the patient at high risk for treatment complications
Patients who have received prior PI3K or CHK therapy
Any other investigational or anti-cancer treatments while participating in this study
Any other active malignancy
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