NCT00875355

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

August 26, 2009

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

April 2, 2009

Last Update Submit

August 25, 2009

Conditions

Breast CancerMetastatic Cancer

Keywords

tumors metastatic to brainstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Response at 6 weeks as assessed by MRI and/or scan

Study Arms (2)

Arm I

EXPERIMENTAL

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

Radiation: radiation therapy

Arm II

EXPERIMENTAL

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

Drug: temozolomideRadiation: radiation therapy

Interventions

temozolomideDRUG

Given orally

Arm II
radiation therapyRADIATION

Patients undergo radiotherapy

Arm IArm II

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Institut Curie Hopital

Paris, 75248, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25355723DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm MetastasisBrain Neoplasms

Interventions

TemozolomideRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Youlia Kirova

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

November 1, 2007

Primary Completion

November 1, 2009

Last Updated

August 26, 2009

Record last verified: 2009-07

Locations

FR(1)