Study on Stereotactic Radiosurgery with Olaparib, Followed by Durvalumab and Doctor's Choice Therapy for Breast Cancer with Brain Metastases
Sponsor: Colette Shen
ClinicalTrials ID:NCT04711824
This clinical trial is testing a combination of focused radiation therapy, a drug called olaparib, and immunotherapy to treat patients with breast cancer that has spread to the brain. The study aims to find out if this approach is safe and effective.
Patient Parameters
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Program Overview
This study is exploring a new treatment for patients with breast cancer that has spread to the brain. It involves using focused radiation therapy (radiosurgery) along with a drug called olaparib, followed by immunotherapy. The study is divided into two phases. In the first phase, different doses of olaparib will be tested to find the safest and most effective dose. In the second phase, patients will receive olaparib and radiosurgery, followed by immunotherapy and a treatment chosen by their doctor. The goal is to see if this combination can help control the cancer.
Eligibility Criteria
Inclusion Criteria
- Able to provide written consent and agree to share health information.
- Diagnosed with breast cancer that is either triple negative or HER2-negative with a BRCA mutation.
- Have new brain metastases confirmed by MRI and plan to undergo focused radiation therapy.
- May have other cancer spread outside the brain.
- Have had previous cancer treatments, except certain combinations of drugs.
- Have a performance status score of 0 to 2, indicating good overall health.
- Weigh more than 30 kg.
- Have a life expectancy of more than 16 weeks.
- Be 18 years or older.
- Have completed previous cancer treatments at least 7 days before starting the study.
- Willing to provide blood and tissue samples for research.
- Have normal organ and bone marrow function based on specific blood tests.
- Women must not be pregnant and must use effective birth control.
- Men must use condoms or abstain from sex during and after treatment.
- Able to understand and follow study procedures.
- Meet any additional criteria specified by the drug manufacturer.
Exclusion Criteria
- Have widespread cancer in the brain lining.
- Need immediate brain surgery.
- Have bleeding in the brain or signs of brain swelling.
- Have had whole brain radiation therapy.
- Have had recent radiation therapy outside the brain.
- Show signs of severe organ damage.
- Have a history of severe brain injury.
- Have received certain cancer treatments within 7 days before the study.
- Have blood disorders like myelodysplastic syndrome or leukemia.
- Have uncontrolled heart conditions.
- Have severe blood cell deficiencies from previous treatments.
- Have lung disease or primary immune deficiencies.
- Have used certain growth factors recently.
- Have HIV or are immunocompromised.
- Are pregnant or breastfeeding.
- Cannot undergo regular MRI or CT scans.
- Have untreated spinal cord compression.
- Cannot swallow pills or have digestive issues.
- Are taking certain medications that affect olaparib.
- Have had a bone marrow transplant.
- Are in another clinical trial.
- Have unresolved side effects from previous treatments.
- Have had major surgery recently.
- Have autoimmune or inflammatory disorders.
- Have uncontrolled illnesses or infections.
- Have had another cancer within 5 years, except certain types.
- Are using immunosuppressive medications.
- Have received a live vaccine recently.
- Are allergic to study drugs.
- Have been in a previous durvalumab study.
- Have had severe side effects from previous immunotherapy.
- Have active infections like tuberculosis or hepatitis.
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