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

Korábbi kezelés

• Brain metastases requiring focal or whole brain radiation will be excluded, as these lesions cannot be biopsied and can have life expectancies <6 months.
• 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
• 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.

Más betegség

• 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)
• Intercurrent illness or other major medical condition or comorbid condition that might affect study participation (uncontrolled renal, pulmonary or hepatic dysfunction or infection)

Életkor

• 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.

Egyéb

• Inability to obtain a biopsy of the tumor as deemed by the study Interventional Radiologist
• Life expectancy less than 6 months
• Renal dysfunction for which cisplatin dose would be considered unsafe.

• 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)