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| ID | Type | Description | Link |
|---|---|---|---|
| A6051029/MOI99056 |
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Evaluation of efficacy of treatment with epirubicin (5 years follow-up). Evaluation of frequency of dose reduction. Evaluation of frequency of neoadjuvant treatment with E(120mg) / C(600mg). Evaluation of unexpected and serious adverse events.
(E=Epirubicin; C =Cyclophosphamide)
Postmarketing surveillance study. Non-Probability Sample
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Interventional Study | Chemotherapy containing Epirubicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epirubicin: Observational Study | Drug | Observational: Chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Free Survival (DFS) | Percentage of participants with DFS who completed 5 year follow-up visit. | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y | |
| Time to Recurrence (DFI) | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients with primary breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 1982 participants were enrolled, however, during database lock, 10 participants were identified as duplicates. Therefore, a total of 1972 unique participants were identified for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Entire Study Population | Includes all groups enrolled in the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all groups enrolled in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| 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 Disease Free Survival (DFS) | Percentage of participants with DFS who completed 5 year follow-up visit. | Intent to treat (ITT) | Posted | Number | Percentage of participants | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y |
|
|
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Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
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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 | Epirubicin | Includes groups enrolled to receive all treatments of epirubicin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Secondary neoplasm |
|
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Time to Progression (TTP) | 16.3% of patients had experienced disease progression by the end of the study. As this is less than 50% the median time to progression is not defined. | Posted | Median | Full Range | months | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y |
|
|
| Secondary | Time to Recurrence (DFI) | Median time to recurrence was not reached. | Posted | Median | Full Range | months | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y |
|
|
| 16 |
| 1,972 |
| 0 |
| 1,972 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Intestinal infarction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Death | General disorders | MedDRA | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Metastases to nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D017437 |
| Skin and Connective Tissue Diseases |