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Brief Title: Olaparib and Radiotherapy in Inoperable Breast Cancer
Official Title: Olaparib Dose Escalation in Combination With High Dose Radiotherapy to the Breast Andregional Lymph Nodes in Patients With Breast Cancer
Study ID: NCT02227082
Brief Summary: The majority of breast cancer patients receive radiotherapy as part of their treatment. Radiotherapy improves both locoregional control and overall survival. In most patients with breast cancer the locoregional recurrence rate (LRR) is low, however still high LRRs are found in certain patient groups, especially in locally advanced, inflammatory and triple negative breast cancer. Olaparib is a potent PARP inhibitor developed as an anti-cancer drug for homologous recombination (HR) defected tumors and as a dose intensifier for chemo- and radiotherapy. The combination of olaparib and radiotherapy is expected to improve locoregional control and thereby overall survival in both breast cancer patients with a high probability of locoregional recurrence and patients with HR deficient tumors. However, this combination treatment has never been tested in humans before. The purpose of this study is to determine the safety and tolerability of radiotherapy to the breast and regional lymph nodes with concurrent olaparib.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
The Netherlands Cancer Institute, Amsterdam, , Netherlands
Name: Gabe Sonke, MD, PhD
Affiliation: The Netherlands Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Marcel verheij, MD, PhD
Affiliation: The Netherlands Cancer Institute
Role: PRINCIPAL_INVESTIGATOR