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

This study has been completed.
Sponsor:
Collaborators:
Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskning
Sanofi
Dako
Information provided by (Responsible Party):
Bent Ejlertsen, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier:
NCT00689156
First received: May 29, 2008
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Drug: Epirubicin, cyclophosphamide and docetaxel
Drug: docetaxel, cyclophosphamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Danish Breast Cancer Cooperative Group:

Primary Outcome Measures:
  • IDFS; invasive disease-free survival [ Time Frame: Within 10-yeras ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Life-long observation ] [ Designated as safety issue: No ]
  • DDFS; distant disease-free survival [ Time Frame: Within 10-years ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: Within 10-years ] [ Designated as safety issue: Yes ]

Enrollment: 2015
Study Start Date: June 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Regimen 1
Epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times three followed by docetaxel 100 mg/m2 intravenously day 1 every 3 weeks times three
Drug: Epirubicin, 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
Other Names:
  • Ellence
  • Taxotere
Experimental: Regimen 2
Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
Drug: docetaxel, cyclophosphamide
Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
Other Name: Taxotere

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689156

Locations
Denmark
Dept. of Oncology; Aalborg Sygehus
Aalborg, Denmark, DK-9000
Dept. of Oncology; Rigshospitalet
Copenhagen, Denmark, DK-2100
Dept. of Oncology; Sydvestjysk Sygehus Esbjerg
Esbjerg, Denmark, DK-6700
Dept. of Oncology; Herlev Hospital
Herlev, Denmark, DK-2730
Dept. of Oncology; Regionshospitalet Herning
Herning, Denmark, DK-7400
Dept. of Oncology; Nordsjællands Hospital Hillerød
Hillerød, Denmark, DK-3400
Dept. of Oncology; Sygehus Syd Næstved
Næstved, Denmark, DK-4700
Dept. of Oncology; Odense University Hospital
Odense, Denmark, DK-5000
Dept. of Oncology; Sygehus Øst Roskilde
Roskilde, Denmark, DK-4000
Dept. of internal medicine; Bornholms Hospital
Rønne, Denmark, DK-3700
Dept. of Oncology; Vejle Sygehus
Vejle, Denmark, DK-7100
Dept. of Oncology; Regionshospitalet Viborg
Viborg, Denmark, DK-8800
Dept. of Oncology; Århus Sygehus
Århus, Denmark, DK-8000
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskning
Sanofi
Dako
Investigators
Principal Investigator: Bent Ejlertsen, M.D. Rigshospitalet, Denmark
Study Director: Henning T. Mouridsen, M.D. Rigshospitalet, Denmark
  More Information

Additional Information:
Publications:
Responsible Party: Bent Ejlertsen, Professor, MD, PhD, Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier: NCT00689156     History of Changes
Other Study ID Numbers: DBCG 07-READ
Study First Received: May 29, 2008
Last Updated: January 3, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Danish Breast Cancer Cooperative Group:
Epirubicin
docetaxel
Adjuvant chemotherapy
DNA Topoisomerases, Type II

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Cyclophosphamide
Epirubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014