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

Breast Cancer Clinical Trial

Official title:

Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00875355
• Other study ID #: CDR0000633496
• Secondary ID: CLCC-IC-RT-TEMOD
• Status: Recruiting
• Phase: Phase 2
• First received: April 2, 2009
• Last updated: August 25, 2009
• Start date: November 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer

• Unresectable disease or patient refused surgery

• Must have brain metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• ANC = 1,500/mm³

• Platelet count = 100,000/mm³

• Liver transaminases = 1.5 times upper limit of normal (ULN)

• Creatinine < 1.5 times ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No carcinomatous meningitis

• No history of cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix

• No other serious concurrent disease that is, in the opinion of the investigator, likely to interfere with study evaluation and treatment

• No contraindications to treatment with temozolomide

• No psychological, familial, social, or geographic situations that preclude clinical follow up

• No patient deprived of liberty or under guardianship

PRIOR CONCURRENT THERAPY:

• No prior brain radiotherapy

• At least 10 days since prior chemotherapy

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• temozolomide
Given orally

Radiation:
• radiation therapy
Patients undergo radiotherapy

Locations

Country	Name	City	State
France	Institut Curie Hopital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response at 6 weeks as assessed by MRI and/or scan			No