Status:
COMPLETED
Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer
Lead Sponsor:
Danish Breast Cancer Cooperative Group
Collaborating Sponsors:
Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskning
Sanofi
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
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 cyclophosph...
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...
Eligibility Criteria
Inclusion
- Trial Population:
- Younger than 35, but at least 18 years of age
- Hormone receptor-negative tumor (ER- and PgR-negative) and 35 to 75 years of age.
- 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.
- Signed informed consent
- Histologically confirmed invasive breast carcinoma which has been micro-radical removed by breast preserving surgery or mastectomy according to DBCG's guideline
- TOP2A normal tumor (score of 0.8 - 2.0)
Exclusion
- Pregnancy or breast-feeding
- Earlier medical cancer treatment, including docetaxel, epirubicin or cyclophosphamide.
- Distant metastases or bilateral breast cancer (excluded after checking by means of chest radiography, bilateral mammography and normal blood samples as a minimum).
- 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.
- Comorbidity score \> 3 (patients with a score of 1-2 start at dose level -1).
- Treatment with a non-approved product or test product in the latest 30 days.
- Known severe hypersensitivity to docetaxel, epirubicin or cyclophosphamide or auxiliary agents in these products.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
2015 Patients enrolled
Trial Details
Trial ID
NCT00689156
Start Date
June 1 2008
End Date
January 1 2013
Last Update
April 5 2018
Active Locations (13)
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1
Dept. of Oncology; Aalborg Sygehus
Aalborg, Denmark, DK-9000
2
Dept. of Oncology; Århus Sygehus
Aarhus, Denmark, DK-8000
3
Dept. of Oncology; Rigshospitalet
Copenhagen, Denmark, DK-2100
4
Dept. of Oncology; Sydvestjysk Sygehus Esbjerg
Esbjerg, Denmark, DK-6700