Clinical trial · Interventional
Radiation Therapy With or Without Temozolomide in Treating Women With Brain Metastases and Breast Cancer
Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo isocentric radiotherapy to the brain 5 times a week for 2 weeks.
- interventionNames
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo radiotherapy as in arm I and receive oral temozolomide once daily for 2 weeks.
- interventionNames
- Drug: temozolomide
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Response at 6 weeks as assessed by MRI and/or scan
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCao 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. PMID 25355723