Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer

Official Title

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiation Therapy Versus Radiation Therapy Alone for Inflammatory Breast Cancer

Summary:

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 tumour cells and shrink tumours. 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.

Trial Description

Primary Outcome:

• Invasive Disease-Free Survival (IDFS)

Secondary Outcome:

• Locoregional Recurrence-Free Interval (Local Disease-Free Interval [LDFI])
• Distant Relapse-Free Survival (Distant Recurrence-Free Survival)
• Overall Survival

Primary Objectives:

• To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiation therapy to the chest wall and regional lymph nodes compared to standard doses of radiation therapy alone to the chest wall and regional lymph nodes.

Secondary Objectives:

• To compare the effect of concurrent administration of olaparib with radiation therapy versus radiation therapy alone on improvement in locoregional control (measured by locoregional recurrence-free interval), distant relapse-free survival, and overall survival in inflammatory breast cancer patients.

Additional Objective:

• 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 registration.

View this trial on ClinicalTrials.gov