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

Institut Curie

Status and phase: Unknown; Phase 2

Conditions: Metastatic Cancer; Breast Cancer

Treatments: Radiation: radiation therapy; Drug: temozolomide

Study type: Interventional

Funder types: Other

Identifiers

NCT00875355

INCA-RECF0630

SCHER-CLCC-IC-RT-TEMODAL

CLCC-IC-2007-01

CLCC-IC-RT-TEMODAL

CDR0000633496

EUDRACT-2007-002531-83

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 2 patient groups

Arm I

Experimental group

Description:

Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.

Treatment:

Radiation: radiation therapy

Arm II

Experimental group

Description:

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

Treatment:

Radiation: radiation therapy

Drug: temozolomide