drugset / Trial / NCT02227082

Olaparib and Radiotherapy in Inoperable Breast Cancer

NCT02227082

Phase 1 Completed 7 enrolled The Netherlands Cancer Institute
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-10-21
Primary completion
2019-09
Completion
2020-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 25 mg
Subject Olaparib Small molecule 50 mg
Subject Olaparib Small molecule 100 mg
Subject Olaparib Small molecule 200 mg
Subject Olaparib Small molecule 300 mg
Subject Olaparib Small molecule 400 mg