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Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer


Phase 3
18 Years
75 Years
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

IDFS; invasive disease-free survival

Outcome Time Frame:

Within 10-yeras

Safety Issue:

Yes

Principal Investigator

Bent Ejlertsen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rigshospitalet, Denmark

Authority:

Denmark: Danish Medicines Agency

Study ID:

DBCG 07-READ

NCT ID:

NCT00689156

Start Date:

June 2008

Completion Date:

January 2013

Related Keywords:

  • Breast Neoplasms
  • Epirubicin
  • docetaxel
  • Adjuvant chemotherapy
  • DNA Topoisomerases, Type II
  • Breast Neoplasms
  • Neoplasms

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