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

Phase 2

• Conditions: Breast Cancer; Metastatic Cancer
• Interventions: Radiation: radiation therapy; Drug: temozolomide

• Registration Number: NCT00875355
• Lead Sponsor: Institut Curie

Brief 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.

Detailed Description

OBJECTIVES:

Primary

* Compare the objective response rate at 6 weeks in women with brain metastases secondary to breast cancer treated with radiotherapy with vs without temozolomide.

Secondary

* Evaluate the tolerability.

* Compare the duration of response.

* Compare local progression-free survival.

* Compare overall survival.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.

* Arm II: Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.

After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months for 2 years.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Status Verified: 2009-07
• Last Update Submitted: 2009-08-25
• Last Update Posted: 2009-08-26
• Primary Completion: 2009-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	radiation therapy	Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
Arm II	radiation therapy	Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
Arm II	temozolomide	Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Response at 6 weeks as assessed by MRI and/or scan

Trial Locations

Locations (1)

Institut Curie Hopital; 🇫🇷 Paris, France