Randomized trial of sequential epirubicin and docetaxel against docetaxel in patients with early operable breast cancer. - READ TOP2A
- Conditions
- Women with operable breast cancer and increased risk of recurrence
- Registration Number
- EUCTR2007-003126-15-DK
- Lead Sponsor
- DBCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1932
· 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
· 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method