Predictors for Response to Dose-dense Docetaxel and Epirubicin Breast Cancer (MEDOBREC)

This study is currently recruiting participants.
Verified May 2012 by University of Bergen
Haukeland University Hospital
Information provided by (Responsible Party):
Per Eystein Lonning, University of Bergen Identifier:
First received: July 3, 2007
Last updated: May 16, 2012
Last verified: May 2012

Molecular markers predicting response to dose dense chemotherapy with epirubicin and docetaxel in sequence for locally advanced breast cancer

Protocol summary.

Principal Investigator Per E Lonning, Professor, Section of Oncology, Department of Medicine

Collaborators. Dept of Surgery - Responsible: Turid Aas, Consultant Surgeon Dept of Molecular Biology - Responsible: Professor Johan Lillehaug Dept of Anatomy and Cellular Biology - Responsible: Professor Rolf Bjerkvig

Participants. Dept of Oncology Gun Anker, Consultant Oncologist Stephanie Geisler, Consultant Oncologist Jurgen Geisler, Consultant Oncologist

Type of Study Phase II, Translational research

Scientific aims: Addressing factors predicting response to dose intensive epirubicin followed by docetaxel sequential therapy

Treatment regimen: epirubicin 60 mg/m2 on a 2 weekly basis x 4 followed by docetaxel 100 mg/m2 2-weekly x 4.

Patients: Breast cancer patients below 65 years of age suffering from large (>4 cm largest diameter, non-inflammatory and / or N2-N3) primary breast cancer.


Clinical aim: Assessing responsiveness to this dose intensive regimen.

Number of patients to be enrolled: 60 - 100

Condition Intervention Phase
Primary Breast Cancer
Other: Pretreatment surgical specimen. Epirubicin 60mg/m2/2 w/4 cycles
Other: docetaxel 2-weekly
Other: pegfilgrastim 6mg injections
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Molecular Markers Predictive Response to Dose Dense Chemotherapy With Epirubicin and Docetaxel in Sequences for Locally Advanced Breast Cancer.

Resource links provided by NLM:

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • To evaluate predictive factors to sequential dose-dense therapy with epirubicin followed by docetaxel in primary locally advanced breast cancer. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate overall response to this dose dense sequential therapy treatment. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: epirubicin/docetaxel seq.
One arm study; Epirubicin 4 cycles 2-weekly intervals, followed by docetaxel 4 cycles, 2 weekly intervals. Each cure with pegfilgrastim.
Other: Pretreatment surgical specimen. Epirubicin 60mg/m2/2 w/4 cycles
Administered 2-weekly 4 cycles.
Other Name: Farmorubicin (Pfizer)
Other: docetaxel 2-weekly
docetaxel 100 mg/m2/2w/4 cycles
Other Name: Taxotere (Aventis).
Other: pegfilgrastim 6mg injections
Administered following each cure on day 2.
Other Name: Neulasta (Amgen)

  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary breast cancer >4cm in diameter and / or lymph node status N2-3.
  • Age 65 years or younger
  • "Limited" distant metastases allowed, but patients with massive distant metastases should be excluded
  • Willing to participate in the study

Exclusion Criteria:

  • Known allergy toward any of the cytotoxic compounds to be administered (epirubicin and doxorubicin)
  • Liver enzymes > 2 times upper normal limit or bilirubin > 3 times upper normal limit
  • Other medical conditions making them unfit for dose-dense therapy
  • Cardiac insufficiency; for patients not to receive trastuzumab, decision whether to exclude such patients will be at the physicians discretion. Considering patients with HER-2 positive tumors who should have trastuzumab, exclusion criteria will be according to the NBCG (Norwegian Breast Cancer Group) general guidelines (
  Contacts and Locations
Please refer to this study by its identifier: NCT00496795

Contact: Gun Anker, MD PhD +47 55 97 20 10
Contact: Hans P Eikesdal, MD 004755972010

Dept of Oncology Recruiting
Bergen, Norway, N-5021
Contact: Gun Anker, MD    004755972010   
Contact: Hans P Eikesdal, MD    004755972010   
Principal Investigator: Per E Lønning, Professor         
Sub-Investigator: Gun B Anker, MD         
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Study Chair: Per E Lonning, MD PhD Section of Oncology, Institute of Medicine, University of Bergen, Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Per Eystein Lonning, Professor, University of Bergen Identifier: NCT00496795     History of Changes
Other Study ID Numbers: Ethics committee 079.06, NSD 14918
Study First Received: July 3, 2007
Last Updated: May 16, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by University of Bergen:
Breast cancer, chemoresistance, predictive markers.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 15, 2014