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

April 3, 2018 updated by: Bent Ejlertsen, Danish Breast Cancer Cooperative Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2015

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9000
        • Dept. of Oncology; Aalborg Sygehus
      • Copenhagen, Denmark, DK-2100
        • Dept. of Oncology; Rigshospitalet
      • Esbjerg, Denmark, DK-6700
        • Dept. of Oncology; Sydvestjysk Sygehus Esbjerg
      • Herlev, Denmark, DK-2730
        • Dept. of Oncology; Herlev Hospital
      • Herning, Denmark, DK-7400
        • Dept. of Oncology; Regionshospitalet Herning
      • Hillerød, Denmark, DK-3400
        • Dept. of Oncology; Nordsjællands Hospital Hillerød
      • Næstved, Denmark, DK-4700
        • Dept. of Oncology; Sygehus Syd Næstved
      • Odense, Denmark, DK-5000
        • Dept. of Oncology; Odense University Hospital
      • Roskilde, Denmark, DK-4000
        • Dept. of Oncology; Sygehus Øst Roskilde
      • Rønne, Denmark, DK-3700
        • Dept. of internal medicine; Bornholms Hospital
      • Vejle, Denmark, DK-7100
        • Dept. of Oncology; Vejle Sygehus
      • Viborg, Denmark, DK-8800
        • Dept. of Oncology; Regionshospitalet Viborg
      • Århus, Denmark, DK-8000
        • Dept. of Oncology; Århus Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Taxotere
  • Ellence
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 Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IDFS; invasive disease-free survival
Time Frame: Within 10-yeras
Within 10-yeras

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Life-long observation
Life-long observation
DDFS; distant disease-free survival
Time Frame: Within 10-years
Within 10-years
Serious adverse events
Time Frame: Within 10-years
Within 10-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Breast Cancer Cooperative Group

Collaborators

Sanofi
Fonden Til Fremme af Klinisk- Eksperimentel Cancerforskning
Dako

Investigators

  • Principal Investigator: Bent Ejlertsen, M.D., Rigshospitalet, Denmark
  • Study Director: Henning T. Mouridsen, M.D., Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBCG 07-READ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on Epirubicin, cyclophosphamide and docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe