An observational study in Breast Neoplasm, sponsored by Pfizer. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2010-12-29.
Sponsored by Pfizer · Observational
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 1,981 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female patients with primary breast cancer
Exclusion Criteria:
Chemotherapy containing Epirubicin
Drug: Epirubicin: Observational Study
Observational: Chemotherapy
Percentage of Participants With Disease Free Survival (DFS)
Percentage of participants with DFS who completed 5 year follow-up visit.
Time frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
Time to Progression (TTP)
Time frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
Time to Recurrence (DFI)
Time frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
| Milestone | Entire Study Population |
|---|---|
| Started | 1972 |
| Completed | 670 |
| Not completed | 1302 |
| Withdrew: Death | 32 |
| Withdrew: Lost to follow-up | 1072 |
| Withdrew: Relapse | 187 |
| Withdrew: Secondary neoplasm | 11 |
Percentage of participants with DFS who completed 5 year follow-up visit.
| Percentage of participants | Epirubicin |
|---|---|
| Percentage of Participants With Disease Free Survival (DFS) | 83.7 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epirubicin | — | 16/1,972 (0.8%) | 0/1,972 (0%) |
| Event | Epirubicin |
|---|---|
| LeukopeniaBlood and lymphatic system disorders | 6/1972 |
| PancytopeniaBlood and lymphatic system disorders | 4/1972 |
| AneaemiaBlood and lymphatic system disorders | 3/1972 |
| NeutropeniaBlood and lymphatic system disorders | 3/1972 |
| Mucosal inflammationGeneral disorders | 3/1972 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/1972 |
| NauseaGastrointestinal disorders | 2/1972 |
| VomitingGastrointestinal disorders | 2/1972 |
| Disease progressionGeneral disorders | 2/1972 |
| Neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/1972 |
| Age Continuous(years) | Entire Study Population |
|---|---|
| Median | 54.73 (25.36 to 80.42) |
| Age, Customized(participants) | Entire Study Population |
|---|---|
| >=20 and <30 years | 12 |
| >=30 and <40 years | 167 |
| >=40 and <50 years | 512 |
| >=50 and <60 years | 568 |
| >=60 and <70 years | 557 |
| >=70 and <80 years | 101 |
| >=80 and <90 years | 1 |
| Unknown | 54 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 1972 |
| Male | 0 |
No study locations are listed for this record.
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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