This phase II trial studies how well radiation therapy with or without olaparib works in
treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays
to kill tumor cells and shrink tumors. Olaparib is an inhibitor of PARP, an enzyme that helps
repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep
cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a
type of targeted therapy. It is not yet known whether radiation therapy with or without
olaparib may work better in treating patients with inflammatory breast cancer.
I. To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast
cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to
the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to
the chest wall and regional lymph nodes.
I. To compare the effect of concurrent administration of olaparib with radiotherapy versus
radiotherapy alone on improvement in locoregional control (measured by locoregional
recurrence-free interval), distant relapse-free survival, and overall survival in
inflammatory breast cancer patients.
I. To collect tissue and whole blood for processing and banking in anticipation of future
correlative studies in this patient population.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive olaparib orally (PO) twice daily (BID) the day before standard
radiation therapy (RT) commences (Day 0) and throughout the RT course until the last day of
RT administration. Olaparib is also continued on weekends (routine days without RT)
throughout the RT course. Patients undergo radiation therapy 5 days per week for 6 weeks in
the absence of disease progression or unacceptable toxicity.
GROUP II: Patients undergo standard radiation therapy 5 days per week for 6 weeks in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 5 weeks, then every 3
months until 3 years after registration, and then every 6 months for up to 8 years after
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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