Olaparib and Radiotherapy in Inoperable Breast Cancer

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02227082
Phase
PHASE1
Status
Completed

Conditions

  • Inflammatory Breast Carcinoma
  • Locally Advanced Malignant Neoplasm
  • Triple-Negative Invasive Breast Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • radiotherapy — RADIATION
    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
  • olaparib — DRUG
    The pre-defined dose levels of olaparib are 25mg QD, 25, 50, 100, 200, 300 and 400 mg BID

Study Details

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.

Key Dates

Start date
Oct 21, 2013
Status verified
Aug 2021
Primary completion
Sep 30, 2019
Completion
Aug 31, 2020

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: radiotherapy and olaparib
    radiotherapy: 61.18 Gy olaparib: dose escalating

Primary Outcome Measure

The incidence of dose limiting toxicities. [ Time Frame: 1 year ]

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