Clinical trial NCT00875355: Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Metastatic Cancer
Keywords: tumors metastatic to brain
stage IV breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-04-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response at 6 weeks as assessed by MRI and/or scan
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie Hopital
Study officials:
affiliation: Institut Curie
name: Youlia Kirova
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.