A Study of Whole Brain Radiation Therapy and Capecitabine in Breast Cancer Participants With Newly Diagnosed Brain Metastasis
NCT ID: NCT00977379
Last Updated: 2016-11-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
24 participants
INTERVENTIONAL
2009-08-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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WBRT Followed by Standard of Care
Participants will receive 3000 centi-Gray (cGy) WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants will be followed during the treatment until the halting of standard of care for any reason (central nervous system \[CNS\] or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
WBRT
3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction).
Standard of Care
The choice of standard of care will be at the discretion of the treating oncologist. The protocol does not specify any particular standard of care treatment.
WBRT+Capecitabine Followed by Capecitabine Maintenance
Participants will receive 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 milligrams per square meter (mg/m\^2) orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m\^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
WBRT
3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction).
Capecitabine
825 mg/m\^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by 1000 mg/m\^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2.
Interventions
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WBRT
3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction).
Capecitabine
825 mg/m\^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by 1000 mg/m\^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2.
Standard of Care
The choice of standard of care will be at the discretion of the treating oncologist. The protocol does not specify any particular standard of care treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed CNS metastasis with at least one brain lesion measuring greater than or equal to (\>/=) 1 centimeter (cm) or two lesions measuring \>/= 0.5 to less than (\<) 1 cm in longest dimension
* Participant not eligible for or refusing surgery or stereotactic radiosurgery
* Eastern cooperative oncology group (EOCG) performance status 0 to 2
Exclusion Criteria
* Leptomeningeal disease
* Known contra-indication to radiotherapy or magnetic resonance imaging (MRI) or capecitabine
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arras, , France
Beuvry, , France
Béziers, , France
Bobigny, , France
Dijon, , France
Le Mans, , France
Lille, , France
Lyon, , France
Montpellier, , France
Nantes, , France
Narbonne, , France
Nice, , France
Paris, , France
Paris, , France
Rouen, , France
Salouël, , France
Countries
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Other Identifiers
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2008-007349-30
Identifier Type: -
Identifier Source: secondary_id
ML21873
Identifier Type: -
Identifier Source: org_study_id