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Slow recruitment
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This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine [Xeloda] | Drug | 900mg/m2 bid po on days 1-14 of each 3-week cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response | The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1). | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chai Yi | 613 | Taiwan | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| trastuzumab [Herceptin] |
| Drug |
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks |
|
| Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death |
| Overall Survival | Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death. | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death |
| Progression-Free Survival | 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. | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death |
| Kaohsiung City |
| 807 |
| Taiwan |
| Taipei | 00112 | Taiwan |
| Taipei | 100 | Taiwan |
| Taipei | 105 | Taiwan |
| Taipei | 112 | Taiwan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine + Trastuzumab | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Overall Response | The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1). | Data were not analyzed due to early termination of the study. | Posted | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death |
|
| |||||||||||||||||||
| Secondary | Time to Disease Progression | 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. | Data were not analyzed due to early termination of the study. | Posted | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death |
|
| |||||||||||||||||||
| Secondary | Overall Survival | Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death. | Data were not analyzed due to early termination of the study. | Posted | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death |
|
| |||||||||||||||||||
| Secondary | Progression-Free Survival | 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. | Data were not analyzed due to early termination of the study. | Posted | Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death |
|
|
Adverse events (AEs) occurring up to 28 days after the last dose of study medication were to be reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capecitabine + Trastuzumab | 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. | 0 | 2 | 0 | 2 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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