Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Breast Cancer Cooperative Group
• Collaborators: Dako; Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskning; Sanofi
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin

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.