Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases (SOLARA)
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- STATUS
- Not Recruiting
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- End date
- Sep 22, 2026
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- participants needed
- 41
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- sponsor
- Colette Shen
Updated on 26 March 2024
Summary
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 and following SRS (1-5 fractions) for up to 28 days total. The number of doses of
Olaparib will be dependent on how long it takes a subject to recover from SRS (ideally the
subject will be off steroids, if they are required, at the start of Cycle 2, with exceptions
outlined later in this section).
Once the subject has recovered from SRS (based on investigator discretion) that will be
considered the DLT period. Cycle 2 will be initiated with physician's choice systemic therapy
and durvalumab. Cycle 2+ will equal 21 days. During Cycles 2 and 3, physician's choice
systemic monotherapy will be given along with durvalumab per protocol. Each cycle will last
21 days. Imaging to evaluate intracranial and extracranial disease will be performed after
Cycle 3, and subjects with response will continue with the systemic therapy and durvalumab
until progression (intracranial or extracranial), unacceptable toxicity or death.
Description
Details
| Condition | Breast Cancer, Brain Metastases, Adult |
|---|---|
| Age | 18years or above |
| Treatment | Durvalumab, Olaparib, Stereotactic Radiosurgery, Physicians Choice systemic chemotherapy |
| Clinical Study Identifier | NCT04711824 |
| Sponsor | Colette Shen |
| Last Modified on | 26 March 2024 |
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