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A Study of Whole Brain Radiation Therapy and Capecitabine in Breast Cancer Participants With Newly Diagnosed Brain Metastasis (XERAD)

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ClinicalTrials.gov Identifier: NCT00977379
Recruitment Status : Terminated (Due to an insufficient number of participants enrolled.)
First Posted : September 15, 2009
Results First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Radiation: WBRT
Drug: Capecitabine
Drug: Standard of Care
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description Participants received 3000 centi-Gray (cGy) whole brain radiation therapy (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 were 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). Participants received 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).
Period Title: Overall Study
Started 12 [1] 12 [1]
Treated 12 11
Completed 0 0
Not Completed 12 12
Reason Not Completed
Withdrawal by Subject             1             1
Death             7             9
Premature Study Termination             4             0
Participant Moving House             0             1
Randomization Error             0             1
[1]
Randomized
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance Total
Hide Arm/Group Description Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death). Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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). Total of all reporting groups
Overall Number of Baseline Participants 12 11 23
Hide Baseline Analysis Population Description
Intent to treat (ITT) population included all randomized participants except one participant from “WBRT+Capecitabine Followed by Capecitabine Maintenance” arm who was randomized by error.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 23 participants
54.8  (15.6) 57.8  (13.1) 56.2  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Female
12
 100.0%
11
 100.0%
23
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Best Objective Central Nervous System (CNS) Response, Assessed by Centralized Independent Expert According to Magnetic Resonance Imaging (MRI) - Intent-to-Treat (ITT) Population
Hide Description Best objective CNS response was defined as having complete response (CR) or partial response (PR) for CNS metastasis, assessed by contrast-enhanced MRI using response evaluation criteria in solid tumors (RECIST). CR: disappearance of all CNS lesions. PR: greater than or equal to (>/=) 30 percent (%) decrease in sum of longest diameters (LD) of CNS lesions taking as reference the baseline sum LD.
Time Frame Baseline until disease progression (PD), unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: percentage of participants
25.0 36.4
2.Primary Outcome
Title Percentage of Participants With Best Objective CNS Response, Assessed by Centralized Independent Expert According to MRI - Per-Protocol (PP) Population
Hide Description Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
PP population included all ITT population participants excluding participants with following major protocol violations: inclusion and exclusion criteria not met; intake of prohibited treatment, protocol design and/or visit dates not respected; and missing values for main criterion without premature withdrawal.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 10 9
Measure Type: Number
Unit of Measure: percentage of participants
20.0 33.3
3.Secondary Outcome
Title Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI
Hide Description Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: percentage of participants
25.0 36.4
4.Secondary Outcome
Title Percentage of Participants With Best Objective CNS Response, Assessed by Investigator According to MRI
Hide Description Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: percentage of participants
50.0 54.5
5.Secondary Outcome
Title Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI in 3 Dimension
Hide Description Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by 3 dimensional MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this outcome was not collected as per changes in planned analysis because sufficient information on the method used was not available.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Participants With Clinical Benefit, Assessed by Investigator According to MRI
Hide Description Clinical benefit was defined as having CR, PR, or stable disease (SD), assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum LD since treatment started. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: percentage of participants
83.3 72.7
7.Secondary Outcome
Title Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to MRI
Hide Description Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: percentage of participants
41.7 27.3
8.Secondary Outcome
Title Duration of CNS Response, Assessed by Investigator According to MRI
Hide Description Duration of CNS response was defined as the time from first documented cranial CR or PR (whichever was recorded first) until the first date CNS recurrence or progression was documented as assessed by contrast-enhanced MRI according to RECIST criteria but without exam for response confirmation. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, number of participants analyzed = participants having had a CR or PR during the study.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 6 6
Median (Full Range)
Unit of Measure: months
6.2
(0 to 16)
2.6
(0 to 11)
9.Secondary Outcome
Title Time to CNS Progression, Assessed by Investigator According to MRI
Hide Description Time to CNS progression was defined as the time from start of study treatment to first documentation of PD or death due to CNS metastasis. PD was assessed by contrast-enhanced MRI according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Median (Full Range)
Unit of Measure: months
3.8
(1 to 17)
3.4
(1 to 15)
10.Secondary Outcome
Title Percentage of Participants With Best Objective Extra-cranial Disease Response, Assessed by Investigator According to Computed Tomography (CT)
Hide Description Best objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: percentage of participants
0.0 9.1
11.Secondary Outcome
Title Percentage of Participants With Objective Extra-cranial Disease Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to CT
Hide Description Objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: percentage of participants
0.0 9.1
12.Secondary Outcome
Title Time to Extra-cranial Disease Progression, Assessed by Investigator According to CT
Hide Description Time to extra-cranial progression was defined as the time from start of study treatment to first documentation of PD or death due to extra-cranial lesions. PD was assessed by CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more extra-cranial lesions and/or unequivocal progression of existing extra-cranial lesions.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Median (Full Range)
Unit of Measure: months
3.5
(1 to 10)
2.7
(1 to 15)
13.Secondary Outcome
Title Time to Progression, Assessed by Investigator According to MRI and CT
Hide Description Time to progression was defined as the time from start of study treatment to first documentation of PD or death due to tumor (CNS or extra-cranial). PD was assessed by MRI or CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS or extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS or extra-cranial lesions and/or unequivocal progression of existing CNS or extra-cranial lesions.
Time Frame Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Median (Full Range)
Unit of Measure: months
3.3
(1 to 10)
2.7
(1 to 15)
14.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the start of study treatment to date of death due to any cause. OS was assessed using Kaplan-Meier analysis.
Time Frame Baseline until death (up to approximately 1 year 5.5 months overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description:
Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 12 11
Median (95% Confidence Interval)
Unit of Measure: months
9.8
(4.3 to 17.0)
4.6
(2.3 to 8.9)
15.Secondary Outcome
Title Absolute Change From Baseline in Mini Mental State (MMS) Total Score
Hide Description MMS was an 11-question measure that tested five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Four items were scored on a scale of 0 to 1; 1 item was scored on a scale of 0 to 2; 3 items were scored on a scale of 0 to 3; and 3 items were scored on a scale of 0 to 5. MMS total score was obtained by adding the scores of all individual items and ranged from 0 to 30, where higher scores indicate better cognitive state.
Time Frame Baseline, Up to end of Treatment (up to 10.6 months overall)
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ITT population. Here, number of participants analyzed = participants evaluable for this outcome.
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
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Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (4.3) 0.9  (3.2)
Time Frame Throughout study (up to approximately 1 year 5.5 months overall)
Adverse Event Reporting Description Safety population included all participants from “WBRT Followed by Standard of Care” arm who received at least one fraction of WBRT and all participants from “WBRT+Capecitabine Followed by Capecitabine Maintenance” arm who received at least one dose of capecitabine or one fraction of WBRT.
 
Arm/Group Title WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Hide Arm/Group Description Participants received 3000 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 were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death). Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 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).
All-Cause Mortality
WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
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WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Affected / at Risk (%) Affected / at Risk (%)
Total   6/12 (50.00%)   6/11 (54.55%) 
Gastrointestinal disorders     
Colitis * 1  0/12 (0.00%)  1/11 (9.09%) 
General disorders     
Asthenia * 1  1/12 (8.33%)  0/11 (0.00%) 
Chest pain * 1  1/12 (8.33%)  0/11 (0.00%) 
General physical health deterioration * 1  1/12 (8.33%)  2/11 (18.18%) 
Nervous system disorders     
Cerebrovascular accident * 1  1/12 (8.33%)  0/11 (0.00%) 
Depressed level of consciousness * 1  0/12 (0.00%)  1/11 (9.09%) 
Epilepsy * 1  1/12 (8.33%)  1/11 (9.09%) 
Intracranial pressure increased * 1  0/12 (0.00%)  1/11 (9.09%) 
Myoclonus * 1  1/12 (8.33%)  0/11 (0.00%) 
Syncope * 1  0/12 (0.00%)  1/11 (9.09%) 
Psychiatric disorders     
Completed suicide * 1  0/12 (0.00%)  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  1/12 (8.33%)  0/11 (0.00%) 
Pulmonary embolism * 1  0/12 (0.00%)  1/11 (9.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
WBRT Followed by Standard of Care WBRT+Capecitabine Followed by Capecitabine Maintenance
Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)   10/11 (90.91%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/12 (8.33%)  0/11 (0.00%) 
Leukopenia * 1  3/12 (25.00%)  1/11 (9.09%) 
Lymphopenia * 1  1/12 (8.33%)  1/11 (9.09%) 
Neutropenia * 1  2/12 (16.67%)  1/11 (9.09%) 
Thrombocytopenia * 1  1/12 (8.33%)  1/11 (9.09%) 
Eye disorders     
Eyelid Oedema * 1  1/12 (8.33%)  0/11 (0.00%) 
Papilloedema * 1  1/12 (8.33%)  0/11 (0.00%) 
Visual Acuity Reduced * 1  2/12 (16.67%)  0/11 (0.00%) 
Visual Impairment * 1  1/12 (8.33%)  0/11 (0.00%) 
Gastrointestinal disorders     
Constipation * 1  0/12 (0.00%)  1/11 (9.09%) 
Diarrhoea * 1  1/12 (8.33%)  3/11 (27.27%) 
Dry Mouth * 1  0/12 (0.00%)  1/11 (9.09%) 
Dysphagia * 1  1/12 (8.33%)  0/11 (0.00%) 
Haemorrhoids * 1  1/12 (8.33%)  0/11 (0.00%) 
Nausea * 1  4/12 (33.33%)  5/11 (45.45%) 
Parotid Gland Enlargement * 1  1/12 (8.33%)  0/11 (0.00%) 
Stomatitis * 1  1/12 (8.33%)  0/11 (0.00%) 
Vomiting * 1  1/12 (8.33%)  6/11 (54.55%) 
General disorders     
Asthenia * 1  6/12 (50.00%)  5/11 (45.45%) 
Chest Pain * 1  2/12 (16.67%)  1/11 (9.09%) 
Facial Pain * 1  1/12 (8.33%)  0/11 (0.00%) 
Fatigue * 1  0/12 (0.00%)  3/11 (27.27%) 
Gait Deviation * 1  0/12 (0.00%)  1/11 (9.09%) 
Hyperthermia * 1  0/12 (0.00%)  1/11 (9.09%) 
Mucosal Inflammation * 1  1/12 (8.33%)  0/11 (0.00%) 
Infections and infestations     
Escherichia Infection * 1  0/12 (0.00%)  1/11 (9.09%) 
Oral Candidiasis * 1  0/12 (0.00%)  1/11 (9.09%) 
Urinary Tract Infection * 1  1/12 (8.33%)  2/11 (18.18%) 
Injury, poisoning and procedural complications     
Fall * 1  0/12 (0.00%)  1/11 (9.09%) 
Lower Limb Fracture * 1  1/12 (8.33%)  0/11 (0.00%) 
Investigations     
Blood Lactate Dehydrogenase Increased * 1  1/12 (8.33%)  0/11 (0.00%) 
Positive Rombergism * 1  0/12 (0.00%)  1/11 (9.09%) 
Weight Decreased * 1  1/12 (8.33%)  0/11 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  3/12 (25.00%)  2/11 (18.18%) 
Hyperglycaemia * 1  0/12 (0.00%)  1/11 (9.09%) 
Hypokalaemia * 1  1/12 (8.33%)  0/11 (0.00%) 
Hyponatraemia * 1  0/12 (0.00%)  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  0/12 (0.00%)  2/11 (18.18%) 
Bone Pain * 1  0/12 (0.00%)  1/11 (9.09%) 
Coccydynia * 1  1/12 (8.33%)  0/11 (0.00%) 
Muscular Weakness * 1  0/12 (0.00%)  1/11 (9.09%) 
Nervous system disorders     
Balance Disorder * 1  0/12 (0.00%)  2/11 (18.18%) 
Convulsion * 1  1/12 (8.33%)  0/11 (0.00%) 
Epilepsy * 1  1/12 (8.33%)  0/11 (0.00%) 
Headache * 1  6/12 (50.00%)  6/11 (54.55%) 
Hemiparesis * 1  1/12 (8.33%)  0/11 (0.00%) 
Hypoaesthesia * 1  2/12 (16.67%)  0/11 (0.00%) 
Intracranial Pressure Increased * 1  1/12 (8.33%)  1/11 (9.09%) 
Psychomotor Skills Impaired * 1  1/12 (8.33%)  0/11 (0.00%) 
Somnolence * 1  0/12 (0.00%)  1/11 (9.09%) 
Tremor * 1  0/12 (0.00%)  1/11 (9.09%) 
Psychiatric disorders     
Anxiety * 1  1/12 (8.33%)  1/11 (9.09%) 
Insomnia * 1  2/12 (16.67%)  0/11 (0.00%) 
Renal and urinary disorders     
Hydronephrosis * 1  1/12 (8.33%)  0/11 (0.00%) 
Pollakiuria * 1  1/12 (8.33%)  1/11 (9.09%) 
Urinary Incontinence * 1  1/12 (8.33%)  2/11 (18.18%) 
Reproductive system and breast disorders     
Vaginal Discharge * 1  0/12 (0.00%)  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/12 (0.00%)  1/11 (9.09%) 
Dyspnoea * 1  0/12 (0.00%)  1/11 (9.09%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  4/12 (33.33%)  2/11 (18.18%) 
Alopecia Areata * 1  1/12 (8.33%)  0/11 (0.00%) 
Dermatitis * 1  0/12 (0.00%)  1/11 (9.09%) 
Pain of Skin * 1  1/12 (8.33%)  0/11 (0.00%) 
Skin Disorder * 1  1/12 (8.33%)  0/11 (0.00%) 
Vascular disorders     
Hypertensive Crisis * 1  1/12 (8.33%)  0/11 (0.00%) 
Hypotension * 1  1/12 (8.33%)  0/11 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Study was prematurely terminated due to an insufficient number of participants enrolled and therefore results are only based on a small sample of breast cancer participants with newly diagnosed brain metastasis and should be considered with caution.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
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Name/Title: Medical Communications
Organization: Hoffman-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00977379     History of Changes
Other Study ID Numbers: ML21873
2008-007349-30
First Submitted: September 14, 2009
First Posted: September 15, 2009
Results First Submitted: September 26, 2016
Results First Posted: November 15, 2016
Last Update Posted: November 15, 2016