Trials / Completed
CompletedNCT02227082
Olaparib and Radiotherapy in Inoperable Breast Cancer
Olaparib Dose Escalation in Combination With High Dose Radiotherapy to the Breast Andregional Lymph Nodes in Patients With Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Locally Advanced Malignant Neoplasm
- Inflammatory Breast Carcinoma
- Triple-Negative Invasive Breast Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | radiotherapy | The whole breast and regional lymph nodes will receive 23 x 2.03 Gy per fraction (total 46.69 Gy) At the macroscopic tumor a added SIB will be given of 23 x 0.63Gy . Total dose: 61.18 Gy |
| DRUG | olaparib | The pre-defined dose levels of olaparib are 25mg QD, 25, 50, 100, 200, 300 and 400 mg BID |
Timeline
- Start date
- 2013-10-21
- Primary completion
- 2019-09-01
- Completion
- 2020-08-01
- First posted
- 2014-08-27
- Last updated
- 2021-08-04
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02227082. Inclusion in this directory is not an endorsement.