Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer. PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.

Timeline

Start

2007-11

Primary completion

2009-11

Completion

—

Outcome

Missed primary endpoint

paper ORRs at 6 weeks were 36% in the WBRT arm and 30% in the WBRT + TMZ arm (NS). PMID 25355723 ↗

paper CONCLUSION: WBRT combined with TMZ did not significantly improve local control and survival in patients with BMs from breast cancer. PMID 25355723 ↗

Publications

• Cao KI, Lebas N, Gerber S, Levy C, Le Scodan R, Bourgier C, Pierga JY, Gobillion A, Savignoni A, Kirova YM. Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer. Ann Oncol. 2015 Jan;26(1):89-94. doi: 10.1093/annonc/mdu488. Epub 2014 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Temozolomide	Small molecule	75 mg/m2	Oral

Indications