Whole Brain Radiotherapy (WBRT) With Sorafenib for Breast Cancer Brain Metastases (BCBM)

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

November 5, 2012

Primary Completion Date

March 1, 2022

Study Completion Date

March 1, 2022

Conditions
Breast CancerBrain Metastases
Interventions
RADIATION

Whole Brain Radiotherapy (WBRT)

WBRT (30 Gy) will be delivered in 10 fractions. Standard opposed lateral fields with multileaf collimation blocking will be used. Treatment will be administered on business days and delivered over an approximate 2 week period. Dexamethasone may be given at the discretion of the treating physician but the dose cannot exceed greater than 16mg daily as it is a strong CYP3A4 inducer. Patients will also receive a proton pump inhibitor with dexamethasone.

DRUG

Sorafenib

The proposed three dose levels of sorafenib during dose escalation are 200 mg, 400mg, and 600 mg administered daily orally. Patients will be enrolled in cohorts of 3.The first three subjects will take sorafenib 200 mg daily within a few hours after the first RT fraction. Sorafenib will be continued concurrently with WBRT (1 fraction /day x 10 fractions) without breaks and then continued after WBRTfor a total of 21 days. If no dose limiting toxicity (DLT) is observed in a cohort of 3 patients until two weeks after completion of WBRT, the next dose level will be evaluated.

Trial Locations (6)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack

Unknown

Memoral Sloan Kettering Cancer Center, Basking Ridge

07748

Memorial Sloan Kettering Monmouth, Middletown

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01724606 - Whole Brain Radiotherapy (WBRT) With Sorafenib for Breast Cancer Brain Metastases (BCBM) | Biotech Hunter | Biotech Hunter