Clinical Trial Finder

Inclusion Criteria:

• - Histologically-confirmed (confirmation done at MSKCC) metastatic adenocarcinoma of the breast.

• - Radiologic evidence of new and/or progressive brain metastases ((≥10 mm in longest dimension) by MRI imaging of the Brain.

• - Planned WBRT based on number (≥ 3 lesions) and/or size (≥ 1 cm) of brain metastases.

• - Age ≥18 years; males and females.

• - Patients who require additional clinically indicated stereotactic radiosurgery (SRS) in addition to WBRT will also be eligible.

• - Life expectancy of >12 weeks.

• - Karnofsky Performance Status (KPS) ≥ 70%.

• - Creatinine ≤2.0 times the upper limit of normal.

• - Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment, must be non-lactating and must agree to use adequate contraception prior to enrollment and for the duration of study participation.

• - No limit to prior therapies with last anti-cancer treatment ≥2 weeks from initiation of WBRT.

Please note: there is no washout period required for trastuzumab, pertuzumab, for patients who have developed new parenchymal brain metastases while on these agents.

Exclusion Criteria:

• - Leptomeningeal metastases Please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain.

• - Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than sorafenib.

• - Craniotomy or any other major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.

• - Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib, and protocol-specified whole-brain radiotherapy.

• - Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding enrollment.

• - Inability to comply with protocol and /or not willing or not available for follow-up assessments.

• - Any condition which in the investigator's opinion makes the patient unsuitable for the study participation.

• - Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes).

• - Claustrophobia.

• - Known allergic reaction to Gd-DTPA.

- Renal insufficiency with recent (<3 month old) creatinine >2.0

Arms

Experimental: Cohort 1

Cohort 1 will include the first ten patients treated with WBRT concomitantly with sorafenib (on a separate phase I trial). We will perform a pilot study of serial FLT-PET imaging of the brain at baseline (< 4 weeks prior to initiation of WBRT), up to 7-10 days post-WBRT and 10-12 weeks after WBRT in patients with metastatic breast cancer to the brain (N=20) treated with WBRT with or without sorafenib.

Experimental: Cohort 2

Cohort 2 will include patients treated with standard WBRT alone. Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to [18F] FLT PET at baseline (< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT.

Interventions

Device: - 18F-FLT-PET Imaging

All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.

Device: - 18F-FLT-PET Imaging

All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.