Genetic Testing in Guiding Treatment for Patients With Brain Metastases (NCT03994796)

🧪 Interventions in This Study

• Abemaciclib (DRUG)
• PI3K Inhibitor paxalisib (DRUG)
• Entrectinib (DRUG)
• Adagrasib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. PRE-REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS) • Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)
2. Participants must have histologically confirmed parenchymal metastatic disease to the brain from any solid tumor. Note: this includes patients that have controlled extracranial disease with progressive intracranial metastasis, as well as patients that have progressive intracranial and extracranial disease.
3. New or progressive brain metastases are defined as any one of the following:
4. Untreated measurable lesions in patients who have received surgery and/or stereotactic radiosurgery (SRS) to one or more other lesions.
5. Progressive measurable lesions after radiation, surgery, or prior systemic therapy
6. Residual or progressive lesions after surgery if asymptomatic.
7. Patients who have had prior whole-brain radiotherapy (WBRT) and/or SRS and then whose lesions have progressed by BM-RANO criteria or there are new lesions, are eligible. Lesions treated with SRS may be eligible if there is unequivocal evidence of progression. For patients with NTRK or ROS1 mutations, entrectinib may be used for newly diagnosed brain metastases. Similarly, for patients with KRAS G12C mutations, MRTX849 may be used for newly diagnosed brain metastases.
8. Patients who have not previously been treated with cranial radiation (e.g. WBRT or SRS) are eligible, but such patients must be asymptomatic or neurologically stable from their CNS metastases.
9. Measurable CNS disease (=\> 10 mm).
10. Ability to obtain magnetic resonance imaging (MRI)s with contrast
11. No surgery within 2 weeks prior to or after registration.
12. No chemotherapy within 14 days prior to registration (Note: for abemaciclib arm, a 21-day chemotherapy washout is required).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (435 Sites)

Showing the first 25 of 435 sites.

• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Anchorage Radiation Therapy Center — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Anchorage Oncology Centre — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• Cancer Center at Saint Joseph's — Phoenix, Arizona
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona
• Mayo Clinic in Arizona — Scottsdale, Arizona
• Mercy Hospital Fort Smith — Fort Smith, Arkansas
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
• Epic Care-Dublin — Dublin, California
• Bay Area Breast Surgeons Inc — Emeryville, California
• Epic Care Partners in Cancer Care — Emeryville, California
• UC San Diego Moores Cancer Center — La Jolla, California
• Cedars Sinai Medical Center — Los Angeles, California
• Contra Costa Regional Medical Center — Martinez, California
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California
• Bay Area Tumor Institute — Oakland, California
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
• Sharp Memorial Hospital — San Diego, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.