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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496795
Recruitment Status : Active, not recruiting
First Posted : July 4, 2007
Last Update Posted : October 30, 2017
Haukeland University Hospital
Information provided by (Responsible Party):
Per Eystein Lonning, University of Bergen

Brief Summary:

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 or disease Intervention/treatment Phase
Stage III Breast Cancer AJCC V7 Other: epirubicin/docetaxel sequential Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : September 2007
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
epirubicin/docetaxel sequential
Epirubicin/docetaxel sequential, i.e. one arm study with Epirubicin 4 cycles 60 mg/m2 q2w, followed by docetaxel 4 cycles, 100 mg/m2 q2w. Each course with pegfilgrastim.
Other: epirubicin/docetaxel sequential
Epirubicin 60 mg/m2, q2w 4 cycles. Followed by docetaxel 100 mg/m2 q2w 4 cycles
Other Name: Farmorubicin (Pfizer)

Primary Outcome Measures :
  1. To evaluate predictive factors to sequential dose-dense therapy with epirubicin followed by docetaxel in primary locally advanced breast cancer. [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. To evaluate overall response to this dose dense sequential therapy treatment. [ Time Frame: 10 years ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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 (

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00496795

Dept of Oncology
Bergen, Norway, N-5021
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

Responsible Party: Per Eystein Lonning, Professor, University of Bergen Identifier: NCT00496795     History of Changes
Other Study ID Numbers: Ethics committee 079.06
NSD 14918
14918 ( Other Identifier: Helse Vest IKT )
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors