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This observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible participants will be followed for up to 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Capecitabine as monotherapy according to prescribing information and normal clinical practice. |
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| Combination Therapy | Capecitabine as part of combination therapy according to prescribing information and normal clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Oral tablet(s) administered according to prescribing information |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment. | Up to approximately 4 years |
| Percentage of Participants Receiving Concomitant Medications During the Study | Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported. | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Relevant Medical History Assessed at Baseline | To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized. | Day 1 |
| Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with metastatic breast cancer initiated on therapy with capecitabine
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbottabad | Pakistan | |||||
274 participants were enrolled in the study; of these, 23 participants from 3 centers were excluded from the analysis due to study termination at those 3 centers. The remaining 251 participants were eligible for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Monotherapy | Capecitabine (XELODA®) as monotherapy according to prescribing information and normal clinical practice. |
| FG001 | Combination Therapy | Capecitabine as part of combination therapy according to prescribing information and normal clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized. |
| Day 1 |
| Mean Survival Time | Up to approximately 4 years |
| Percentage of Participants With Adverse Events | Up to approximately 4 years |
| Faisalabad |
| Pakistan |
| Gujranwala | Pakistan |
| Hyderābād | Pakistan |
| Islamabad | 44000 | Pakistan |
| Islamabad | Pakistan |
| Karachi | 74700 | Pakistan |
| Karachi | 75500 | Pakistan |
| Karachi | Pakistan |
| Lahore | 54600 | Pakistan |
| Lahore | Pakistan |
| Multan | Pakistan |
| Peshwar | Pakistan |
| Rawalpindi | 46000 | Pakistan |
| Rawalpindi | Pakistan |
| COMPLETED |
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| NOT COMPLETED |
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Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).
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| ID | Title | Description |
|---|---|---|
| BG000 | Monotherapy | Capecitabine as monotherapy according to prescribing information and normal clinical practice. |
| BG001 | Combination Therapy | Capecitabine as part of combination therapy according to prescribing information and normal clinical practice. |
| BG002 | Total | Total of all reporting groups |
| 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, Continuous | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | 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 | Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy | To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment. | Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available). | Posted | Number | percentage of participants | Up to approximately 4 years |
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| Primary | Percentage of Participants Receiving Concomitant Medications During the Study | Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported. | Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available). | Posted | Number | percentage of participants | Up to approximately 4 years |
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| Secondary | Percentage of Participants With Relevant Medical History Assessed at Baseline | To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized. | Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available). | Posted | Number | percentage of participants | Day 1 |
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| Secondary | Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline | To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized. | Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available). | Posted | Number | percentage of participants | Day 1 |
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| Secondary | Mean Survival Time | Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available). | Posted | Mean | 95% Confidence Interval | Months | Up to approximately 4 years |
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| Secondary | Percentage of Participants With Adverse Events | Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment). | Posted | Number | percentage of participants | Up to approximately 4 years |
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Up to approximately 4 years
Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).
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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 | Monotherapy | Capecitabine as monotherapy according to prescribing information and normal clinical practice. | 85 | 188 | 73 | 188 | ||
| EG001 | Combination Therapy | Capecitabine as part of combination therapy according to prescribing information and normal clinical practice. | 42 | 63 | 42 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Cardiopulmonary Arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Disease Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Vomitting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Melena | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Hematemesis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Head Ache | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Body Ache | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Drowsiness | General disorders | MedDRA (11.0) | Systematic Assessment |
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| High grade fever | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Fever | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Diabetic Coma | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Semi conscous/Unconsciousness | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Multiple Organ Failure | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Hepatorenal failure | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
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| Hepatic Encephalopathy | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
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| Hepatic failure with Ascites | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Cerebral Inflammation | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Pyogenic Meningitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Septicemia & Anaemia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Infected chest wound | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Jaundice | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Pain in sternum | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Hemiplegia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Generalized Fits | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (11.0) | Systematic Assessment |
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| Excessive bleeding from Right breast mass | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
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| Nodules on Right chest & Axilla | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
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| Acute Renal Failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Respiratory Distress/Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Aspiration Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Chest Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Skin cutaneous Infiltration | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Peripheral edema | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Hand-and-Foot Syndrome | Skin and subcutaneous tissue disorders | MedDRA (11.0) | 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 | 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 |
| 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 |
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| Male |
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| Third Line |
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