Women with operable breast cancer and increased risk of recurrence
Conditions
Interventions
Product Name: Farmorubicin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: epirubicin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: up to
Concentration numbe
Sponsors
DBCG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Radical surgery for early breast cancer according to DBCG guidelines · Histological confirmation of invasive breast cancer · TOP2A negative tumor · Age 18 to 34 years · Hormone receptor negative tumor and age 35 or older · Hormone receptor positive tumor, age 35 to 59 years, and either node positive disease, tumor size > 2 cm, grade II or III or HER2 positive · Verbal and written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Pregnancy · Prior chemotherapy for any cancer · Bilateral breast cancer or distant metastasis · Active or uncontrolled cancer · High co-morbidity score · Treatment with a non-approved drug within 30 days · Known hypersensitivity to any or the studie drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare invasive disease-free survival after after chemotherapy with sequential DC (docetaxel plus cyclophosphamide) followed by EC (epirubicin plus cyclophosphamide) against DC.;Secondary Objective: To compare overall survival and survival without distant recurrence and the frequence og serious adverse events after sequential DC and EC against DC.;Primary end point(s): Invasive disease-free survival | — |
Countries
Denmark
Outcome results
None listed