Breast Neoplasms
Conditions
Keywords
Epirubicin, docetaxel, Adjuvant chemotherapy, DNA Topoisomerases, Type II
Brief summary
The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.
Detailed description
In DBCG trial 89D we in more than 1,200 patients showed that substitution in CMF chemotherapy of methotrexate with epirubicin improves survival for patients with primary and operable breast cancer. In a retrospective evaluation we have also shown that approximately 20% of all patients in 89D have tumors with numerical changes of the TOP2A gene, and that only patients with abnormal TOP2A benefit from epirubicin. In the current trial the DBCG wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.
Interventions
DRUGEpirubicin, cyclophosphamide and docetaxel
Epirubicin 90 mg/m2 iv day 1 every 3 weeks plus Cyclophosphamide 600 mg/m2 iv day 1 every 3 weeks times 3 followed by Docetaxel 100 mg/m2 iv day 1 every 3 weeks times 3
Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
Sponsors
Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskning
Sanofi
Dako
Danish Breast Cancer Cooperative Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Trial Population: 1. Younger than 35, but at least 18 years of age 2. Hormone receptor-negative tumor (ER- and PgR-negative) and 35 to 75 years of age. 3. Hormone receptor-positive tumor, 35 to 59 years of age and presenting at least one of the following characteristics: spread to lymph nodes, tumor \> 2 cm, degree of malignancy II-III or HER2-positive. Inclusion Criteria: 1. Signed informed consent 2. Histologically confirmed invasive breast carcinoma which has been micro-radical removed by breast preserving surgery or mastectomy according to DBCG's guideline 3. TOP2A normal tumor (score of 0.8 - 2.0)
Exclusion criteria
1. Pregnancy or breast-feeding 2. Earlier medical cancer treatment, including docetaxel, epirubicin or cyclophosphamide. 3. Distant metastases or bilateral breast cancer (excluded after checking by means of chest radiography, bilateral mammography and normal blood samples as a minimum). 4. Other active, malign disease in the latest 5 years, except for adequately treated and cured carcinoma in situ cervices uteri or non-melanoma skin cancer. 5. Comorbidity score \> 3 (patients with a score of 1-2 start at dose level -1). 6. Treatment with a non-approved product or test product in the latest 30 days. 7. Known severe hypersensitivity to docetaxel, epirubicin or cyclophosphamide or auxiliary agents in these products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IDFS; invasive disease-free survival | Within 10-yeras |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | Life-long observation |
| DDFS; distant disease-free survival | Within 10-years |
| Serious adverse events | Within 10-years |
Countries
Denmark
Outcome results
None listed