Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy. (NCT NCT01290718)
NCT ID: NCT01290718
Last Updated: 2014-12-17
Results Overview
The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
TERMINATED
PHASE2
4 participants
Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
2014-12-17
Participant Flow
Participant milestones
| Measure |
Capecitabine Plus (+) Trastuzumab
Participants received capecitabine 900 milligrams per square meter (mg/m\^2) orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
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4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
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4
|
Reasons for withdrawal
| Measure |
Capecitabine Plus (+) Trastuzumab
Participants received capecitabine 900 milligrams per square meter (mg/m\^2) orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
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|---|---|
|
Overall Study
Early termination of the study
|
4
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Baseline Characteristics
A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.
Baseline characteristics by cohort
| Measure |
Capecitabine + Trastuzumab
n=4 Participants
Participants received capecitabine 900 mg/m\^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
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|---|---|
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Age, Continuous
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53.75 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or DeathPopulation: Data were not analyzed due to early termination of the study.
The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or DeathPopulation: Data were not analyzed due to early termination of the study.
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or DeathPopulation: Data were not analyzed due to early termination of the study.
Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or DeathPopulation: Data were not analyzed due to early termination of the study.
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented.
Outcome measures
Outcome data not reported
Adverse Events
Capecitabine + Trastuzumab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER