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NCT Number: NCT00689156

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Dept. of Oncology; Aalborg Sygehus, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Epirubicin, cyclophosphamide and docetaxel

Drug

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

Other names: Ellence, Taxotere

docetaxel, cyclophosphamide

Drug

Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six

Other names: Taxotere

Primary outcomes

  1. IDFS; invasive disease-free survival

    Time frame: Within 10-yeras

Secondary outcomes

  1. Overall survival

    Time frame: Life-long observation

  2. DDFS; distant disease-free survival

    Time frame: Within 10-years

  3. Serious adverse events

    Time frame: Within 10-years

Sponsors and collaborators

Lead sponsor

Danish Breast Cancer Cooperative Group

Other

Collaborators

  • Dako
  • Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskning
  • Sanofi

Registry information

Official study title

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

Acronym: READ

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 3, 2008
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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