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This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in participants with HER2-negative metastatic breast cancer. Participants will be followed for approximately 6 months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving Capecitabine/Docetaxel | Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | Participants received capecitabine according to individualized physician-prescribed regimen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause. | approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure | The time from enrollment to discontinuation of any drug of the treatment combination. | approximately 2 years |
| Overall Response Rate | The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with HER2-negative metastatic breast cancer initiated on first-line therapy with Xeloda in combination with docetaxel
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budapest | 1067 | Hungary | ||||
46 participants were enrolled in the study and included in safety assessments. 45 participants were included in other assessments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Receiving Capecitabine/Docetaxel | Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| docetaxel | Drug | Participants received docetaxel according to individualized physician-prescribed regimens. |
|
| approximately 2 years |
| Clinical Benefit Rate | The percentage of participants with an overall response (complete or partial remission) or with stable disease. | approximately 2 years |
| Duration of Treatment With Xeloda | approximately 2 years |
| Percentage of Capecitabine Dose Modifications | approximately 2 years |
| Number of Participants With Adverse Events | approximately 2 years |
| Budapest |
| 1122 |
| Hungary |
| Budapest | 1125 | Hungary |
| Budapest | 1145 | Hungary |
| Debrecen | 4032 | Hungary |
| Gyula | 5700 | Hungary |
| Kaposvár | 7400 | Hungary |
| Kecskemét | 6000 | Hungary |
| Miskolc | 3501 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Szeged | 6720 | Hungary |
| Szombathely | 9700 | Hungary |
| Veszprém | 8200 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Evaluable Participants |
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| COMPLETED |
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| NOT COMPLETED |
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All participants were female.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Capecitabine/Docetaxel | Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Progression-free Survival (PFS) | The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause. | Posted | Median | Standard Deviation | months | approximately 2 years |
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| Secondary | Time to Treatment Failure | The time from enrollment to discontinuation of any drug of the treatment combination. | Posted | Mean | Standard Deviation | months | approximately 2 years |
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| ||||||||||||||||||||||||||
| Secondary | Overall Response Rate | The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice. | Posted | Number | percentage of participants | approximately 2 years |
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| Secondary | Clinical Benefit Rate | The percentage of participants with an overall response (complete or partial remission) or with stable disease. | Posted | Number | percentage of participants | approximately 2 years |
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| ||||||||||||||||||||||||||||
| Secondary | Duration of Treatment With Xeloda | Posted | Mean | Standard Deviation | treatment cycle | approximately 2 years |
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| Secondary | Percentage of Capecitabine Dose Modifications | Posted | Number | percentage of doses | approximately 2 years |
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| Secondary | Number of Participants With Adverse Events | 46 participants enrolled in the study were evaluable with regards to tolerability; however, 1 participant did not meet the eligibility criteria, was excluded from the efficacy analyses, but was included in the safety analyses. | Posted | Number | participants | approximately 2 years |
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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 | Participants Receiving Capecitabine/Docetaxel | Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens. | 8 | 46 | 21 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Heart Failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Disease Progression | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Mucositis | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Mucositis | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Palmoplantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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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 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 |
| 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 |
| D000077143 | Docetaxel |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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