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8110 Gatehouse Road, Falls Church, VA 22042

Genomically-Guided Treatment in Brain Metastases

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03994796

Background Information

The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes. The study will attempt to find out if this approach is better or worse than the usual approach for metastatic cancer.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Inova Schar Cancer Institute
3580 Joseph Siewick Dr., Suite 403
Fairfax, VA 22033

A department of Inova Fair Oaks Hospital

Eligibility Information

  • Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy)
  • Histologically confirmed metastatic disease to the brain from any solid tumor
  • Measurable CNS disease (>10 mm)
  • Ability to obtain MRIs
  • New or progressive CNS lesions after systemic therapy or prior radiotherapy
  • No surgery within 2 weeks prior to or after registration
  • No chemotherapy within 14 days prior to registration
  • For HER2-positive breast cancer received prior HER-2 directed therapy in the metastatic setting
  • For triple negative breast cancer (TNBC), at least one chemotherapy in the metastatic setting
  • For ER/PR+ breast cancer, at least one endocrine therapy in the metastatic setting
  • Breast cancer patients who have received ribociclib or palbociclib are eligible as long as there is documentation of
  • CDK4 pathway alteration on a biopsy at the point of progression post-ribociclib or palbociclib
  • Tissue available for sequencing (any brain metastasis tissue and extracranial site from any prior resection or biopsy)
  • Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastasis and extracranial site
  • Age ≥ 18 years
  • ECOG Performance Status 0-2
  • Adequate organ function
  • Additional eligibility in protocol

Ineligibility Information

  • Pregnancy
  • Leptomeningeal involvement
  • Uncontrolled medical comorbidities per investigator discretion
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong
    CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.
  • For GDC-0084 arm: Recent acute myocardial infarction in the last 6 months or current angina pectoris are excluded
  • Previously been treated with cranial radiation
  • Patients with personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
  • Additional ineligibility in protocol

For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03994796