Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer
READ
Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer
1 other identifier
interventional
2,015
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2008
Longer than P75 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedApril 5, 2018
January 1, 2013
4.6 years
May 29, 2008
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IDFS; invasive disease-free survival
Within 10-yeras
Secondary Outcomes (3)
Overall survival
Life-long observation
DDFS; distant disease-free survival
Within 10-years
Serious adverse events
Within 10-years
Study Arms (2)
Regimen 1
ACTIVE COMPARATOREpirubicin 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
Regimen 2
EXPERIMENTALDocetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
Interventions
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
Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Danish Breast Cancer Cooperative Grouplead
- Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskningcollaborator
- Sanoficollaborator
- Dakocollaborator
Study Sites (13)
Dept. of Oncology; Aalborg Sygehus
Aalborg, DK-9000, Denmark
Dept. of Oncology; Århus Sygehus
Aarhus, DK-8000, Denmark
Dept. of Oncology; Rigshospitalet
Copenhagen, DK-2100, Denmark
Dept. of Oncology; Sydvestjysk Sygehus Esbjerg
Esbjerg, DK-6700, Denmark
Dept. of Oncology; Herlev Hospital
Herlev, DK-2730, Denmark
Dept. of Oncology; Regionshospitalet Herning
Herning, DK-7400, Denmark
Dept. of Oncology; Nordsjællands Hospital Hillerød
Hillerød, DK-3400, Denmark
Dept. of Oncology; Sygehus Syd Næstved
Næstved, DK-4700, Denmark
Dept. of Oncology; Odense University Hospital
Odense, DK-5000, Denmark
Dept. of Oncology; Sygehus Øst Roskilde
Roskilde, DK-4000, Denmark
Dept. of internal medicine; Bornholms Hospital
Rønne, DK-3700, Denmark
Dept. of Oncology; Vejle Sygehus
Vejle, DK-7100, Denmark
Dept. of Oncology; Regionshospitalet Viborg
Viborg, DK-8800, Denmark
Related Publications (6)
Moller S, Jensen MB, Ejlertsen B, Bjerre KD, Larsen M, Hansen HB, Christiansen P, Mouridsen HT; Danish Breast Cancer Cooperative Group. The clinical database and the treatment guidelines of the Danish Breast Cancer Cooperative Group (DBCG); its 30-years experience and future promise. Acta Oncol. 2008;47(4):506-24. doi: 10.1080/02841860802059259.
PMID: 18465317BACKGROUNDKnoop AS, Knudsen H, Balslev E, Rasmussen BB, Overgaard J, Nielsen KV, Schonau A, Gunnarsdottir K, Olsen KE, Mouridsen H, Ejlertsen B; Danish Breast Cancer Cooperative Group. retrospective analysis of topoisomerase IIa amplifications and deletions as predictive markers in primary breast cancer patients randomly assigned to cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, epirubicin, and fluorouracil: Danish Breast Cancer Cooperative Group. J Clin Oncol. 2005 Oct 20;23(30):7483-90. doi: 10.1200/JCO.2005.11.007.
PMID: 16234514BACKGROUNDEjlertsen B, Tuxen MK, Jakobsen EH, Jensen MB, Knoop AS, Hojris I, Ewertz M, Balslev E, Dano H, Vestlev PM, Kenholm J, Nielsen DL, Bechmann T, Andersson M, Cold S, Nielsen HM, Maae E, Carlsen D, Mouridsen HT. Adjuvant Cyclophosphamide and Docetaxel With or Without Epirubicin for Early TOP2A-Normal Breast Cancer: DBCG 07-READ, an Open-Label, Phase III, Randomized Trial. J Clin Oncol. 2017 Aug 10;35(23):2639-2646. doi: 10.1200/JCO.2017.72.3494. Epub 2017 Jun 29.
PMID: 28661759BACKGROUNDJensen MB, Balslev E, Knoop AS, Tuxen MK, Hojris I, Jakobsen EH, Cold S, Dano H, Glavicic V, Kenholm J, Ejlertsen B. Adjuvant Docetaxel and Cyclophosphamide With or Without Epirubicin for Early Breast Cancer: Final Analysis of the Randomized DBCG 07-READ Trial. J Clin Oncol. 2025 Feb;43(4):373-380. doi: 10.1200/JCO.24.00836. Epub 2024 Oct 23.
PMID: 39442040DERIVEDFei F, Messina C, Slaets L, Chakiba C, Cameron D, Bogaerts J, Bonnefoi H. Tumour size is the only predictive factor of distant recurrence after pathological complete response to neoadjuvant chemotherapy in patients with large operable or locally advanced breast cancers: a sub-study of EORTC 10994/BIG 1-00 phase III trial. Eur J Cancer. 2015 Feb;51(3):301-9. doi: 10.1016/j.ejca.2014.11.023. Epub 2015 Jan 8.
PMID: 25578377DERIVEDEckhoff L, Knoop A, Jensen MB, Ewertz M. Persistence of docetaxel-induced neuropathy and impact on quality of life among breast cancer survivors. Eur J Cancer. 2015 Feb;51(3):292-300. doi: 10.1016/j.ejca.2014.11.024. Epub 2014 Dec 22.
PMID: 25541155DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bent Ejlertsen, M.D.
Rigshospitalet, Denmark
- STUDY DIRECTOR
Henning T. Mouridsen, M.D.
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
April 5, 2018
Record last verified: 2013-01