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Breast NeoplasmsPhase 3READNCT00689156

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

A Phase 3 study testing Epirubicin, cyclophosphamide and docetaxel and docetaxel, cyclophosphamide in people with Breast Neoplasms, run by Danish Breast Cancer Cooperative Group at 13 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Epirubicin, cyclophosphamide and docetaxel and docetaxel, cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,015 participants
Where
13 sitesDenmark
Study dates
Jun 2008to Jan 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Denmark13 sites

  • Dept. of Oncology; Aalborg Sygehus

    Aalborg, DK-9000

  • Dept. of Oncology; Århus Sygehus

    Aarhus, DK-8000

  • Dept. of Oncology; Rigshospitalet

    Copenhagen, DK-2100

  • Dept. of Oncology; Sydvestjysk Sygehus Esbjerg

    Esbjerg, DK-6700

  • Dept. of Oncology; Herlev Hospital

    Herlev, DK-2730

  • Dept. of Oncology; Regionshospitalet Herning

    Herning, DK-7400

  • Dept. of Oncology; Nordsjællands Hospital Hillerød

    Hillerød, DK-3400

  • Dept. of Oncology; Sygehus Syd Næstved

    Næstved, DK-4700

  • Dept. of Oncology; Odense University Hospital

    Odense, DK-5000

  • Dept. of internal medicine; Bornholms Hospital

    Rønne, DK-3700

  • Dept. of Oncology; Sygehus Øst Roskilde

    Roskilde, DK-4000

  • Dept. of Oncology; Vejle Sygehus

    Vejle, DK-7100

  • Dept. of Oncology; Regionshospitalet Viborg

    Viborg, DK-8800

Other trials in Denmark

About this study

Official title: Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A 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.

Read the 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.

Being tested
Epirubicin, cyclophosphamide and docetaxel, docetaxel, cyclophosphamide
Keywords
Epirubicin, docetaxel, Adjuvant chemotherapy, DNA Topoisomerases, Type II
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epirubicin, cyclophosphamide and docetaxelDrug

    Also called Ellence, Taxotere

    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, cyclophosphamideDrug

    Also called Taxotere

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

Study groups in NCT00689156
Study groupRoleWhat they receive
Regimen 1Active 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
Receives: Drug: Epirubicin, cyclophosphamide and docetaxel
Regimen 2ExperimentalDocetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
Receives: Drug: docetaxel, cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IDFS; invasive disease-free survival

    Measured: Within 10-yeras

Secondary outcomes (3)

  1. Overall survival

    Measured: Life-long observation

  2. DDFS; distant disease-free survival

    Measured: Within 10-years

  3. Serious adverse events

    Measured: Within 10-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,015 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00689156
Sponsor's protocol ID
DBCG 07-READ
Acronym
READ
Status last verified
Jan 2013
First submitted
29 May 2008
Last updated
5 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18465317

  • Knoop 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.

    PubMed 16234514

  • Ejlertsen 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.

    PubMed 28661759

  • Jensen 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.

    PubMed 39442040

  • Fei 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.

    PubMed 25578377

  • Eckhoff 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.

    PubMed 25541155

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epirubicin, cyclophosphamide and docetaxel and docetaxel, cyclophosphamide in people with Breast Neoplasms, run by Danish Breast Cancer Cooperative Group at 13 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IDFS; invasive disease-free survival (time frame: Within 10-yeras). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00689156, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.

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