Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer (READ)
This study has been completed.
Sponsor:
Danish Breast Cancer Cooperative Group
Collaborators:
Fonden til fremme af klinisk eksperimentel cancerforskning vedrørende c. mammae
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
|
|
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:
- 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.
Contacts and Locations
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 vedrørende c. mammae
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 Neoplasms by Site Breast Diseases Skin Diseases Cyclophosphamide Docetaxel Epirubicin Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on June 17, 2013