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

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Cedars-Sinai Medical Center
• Treatments: Cisplatin

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.

• Use of an effective means of contraception in women of child-bearing potential

• Ability to comprehend and sign informed consent

• Adequate organ and marrow function within 14 days prior to study entry, defined as:

• Absolute neutrophil count (ANC)>1000/mm3

• Hemoglobin >9 gm/dl

• Platelets >100,000/mm3

• Serum creatinine <1.5 mg/dl OR creatinine clearance of ≥ 50 cc/min

• SGOT/SGPT<2.5X institutional ULN (<5X ULN if known liver metastases)

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.

• Concurrent active malignancy other than non-melanomatous skin cancer or carcinoma in-situ of the cervix, unless treatment for the previous cancer was completed >2 years prior to study entry and patient has remained disease-free.