A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy

Memorial Sloan Kettering Cancer Center7 sites in 1 country49 target enrollmentApril 14, 2015

ConditionsLocally Recurrent/Metastatic Triple Negative Breast Cancer

Interventionsexternal beam radiation therapy cisplatin Biopsy of Target Tumor

Drugscisplatin

Overview

Phase: Phase 2
Intervention: external beam radiation therapy
Conditions: Locally Recurrent/Metastatic Triple Negative Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 49
Locations: 7
Primary Endpoint: Response (RECIST 1.1 vs. PET Response Criteria (PRC) as Measurement Tools for Treatment Response)
Status: Active, Not Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being done to find out if the results of a pre-treatment biopsy can predict response to cisplatin and radiation treatment for patients with metastatic or recurrent triple negative breast cancer.

Registry

clinicaltrials.gov

Start Date

April 14, 2015

End Date

April 14, 2028

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically-confirmed invasive triple negative breast cancer (ER \<1%, PR \<1%, her-2-neu 0-1+ by IHC or FISH-negative) or as determined by MD discretion
•Radiation to the recurrent or metastatic site is clinically indicated and would be considered standard care for palliation or for locoregional control
•Age ≥18 years
•Tumor to be irradiated is measurable by RECIST 1.1 or PRC
•Willingness to undergo tumor biopsy prior to initiation of treatment
•Life expectancy greater than 6 months
•ECOG performance status 0-2
•Any prior chemotherapy is allowed including prior treatment with platinum-containing chemotherapy
•Prior treatment with FDA-approved or investigational biologics or novel molecularly target therapies, including oral or IV formulations, are permitted.
•Patients must be off prior targeted therapy for at least 14 days prior to study biopsy.

Exclusion Criteria

•Unmeasurable target tumor site by RECIST 1.1 or PRC (ex: lesions \<2 cm on CT or MR scan, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis, non-FDG-avid skin lesions)
•Brain metastases requiring focal or whole brain radiation will be excluded, as these lesions cannot be biopsied and can have life expectancies \<6 months.
•Inability to obtain a biopsy of the tumor as deemed by the study Interventional Radiologist
•Prior chemotherapy completed \<7 days prior to planned study entry
•Prior RT is allowed and must have been completed more than 7 days before planned study entry.
•Note: For re-irradiation cases, standard departmental guidelines should be followed so as to not exceed normal tissue
•Life expectancy less than 6 months
•Intercurrent illness or other major medical condition or comorbid condition that might affect study participation (uncontrolled renal, pulmonary or hepatic dysfunction or infection)
•Renal dysfunction for which cisplatin dose would be considered unsafe.
•Women on study must be neither pregnant nor nursing nor expected to become pregnant during therapy. For premenopausal women, negative pregnancy test within 14 days of RT is required.