Breast Neoplasm
Conditions
Keywords
Breast Cancer, Neoadjuvant Treatment, Chemotherapy, Adjuvant, Epirubicin
Brief summary
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)
Detailed description
Postmarketing surveillance study. Non-Probability Sample
Interventions
DRUGEpirubicin: Observational Study
Observational: Chemotherapy
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Pre- and postmenopausal female patients with histologically confirmed primary breast cancer
Exclusion criteria
* Metastatic breast cancer, locally advanced or recurrent breast cancer, previous cancer history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Free Survival (DFS) | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y | Percentage of participants with DFS who completed 5 year follow-up visit. |
Secondary
| Measure | 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 |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes all groups enrolled in the study | 1,972 |
| Total | 1,972 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 32 |
| Overall Study | Lost to Follow-up | 1,072 |
| Overall Study | Relapse | 187 |
| Overall Study | Secondary neoplasm | 11 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age Continuous | 54.73 years |
| Age, Customized >=20 and <30 years | 12 participants |
| Age, Customized >=30 and <40 years | 167 participants |
| Age, Customized >=40 and <50 years | 512 participants |
| Age, Customized >=50 and <60 years | 568 participants |
| Age, Customized >=60 and <70 years | 557 participants |
| Age, Customized >=70 and <80 years | 101 participants |
| Age, Customized >=80 and <90 years | 1 participants |
| Age, Customized Unknown | 54 participants |
| Sex: Female, Male Female | 1972 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,972 |
| serious Total, serious adverse events | 16 / 1,972 |
Outcome results
Primary
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
Population: Intent to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epirubicin | Percentage of Participants With Disease Free Survival (DFS) | 83.7 Percentage of participants |
Secondary
Time to Progression (TTP)
Time frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
Population: 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.
Secondary
Time to Recurrence (DFI)
Time frame: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
Population: Median time to recurrence was not reached.