Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

This study is a Phase I/II study evaluating the safety and effectiveness of focused radiation therapy (radiosurgery) together with olaparib, followed by immunotherapy, for patients with brain metastases from triple negative or BRCA-mutated breast cancers. This study will have a Phase I portion in which subjects will be enrolled based on 3+3 dose escalation rules. Three dose levels of olaparib will be studied. Cycle 1 of study treatment will consist of Olaparib given twice daily concurrently with stereotactic radiosurgery (SRS). Olaparib will start one week prior to SRS and continue during an

Trial Details

NCT ID
NCT04711824
Phase
PHASE1 / PHASE2
Sponsor
Colette Shen
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Olaparib
  • Stereotactic Radiosurgery
  • Durvalumab
  • Physicians Choice systemic chemotherapy
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Hollywood, Florida, United States|26.0112,-80.14949
  • Indianapolis, Indiana, United States|39.76838,-86.15804
  • New York, New York, United States|40.71427,-74.00597
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key Eligibility Criteria

  • Able and willing to provide written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE…
  • Subject has histologically confirmed diagnosis of breast cancer per AJCC 8th edition meeting any of the following criteria: 1) triple negative, def…
  • Subject has diagnosis of new brain metastasis by MRI, with a plan to undergo stereotactic radiosurgery (SRS) (up to 15 untreated metastases and at …
  • Subject may have other sites of extracranial metastatic disease (does not need to be stable, as long as no signs of impending visceral crisis).

For full eligibility, visit ClinicalTrials.gov.

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