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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Per Eystein Lonning, University of Bergen
ClinicalTrials.gov Identifier:
NCT00496795
First received: July 3, 2007
Last updated: May 18, 2016
Last verified: May 2016
  Purpose

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
Stage III Breast Cancer AJCC V7
Other: epirubicin/docetaxel sequential
Phase 2

Study Type: Interventional
Study Design: 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: May 2026
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 (www.NBCG.net).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00496795

Locations
Norway
Dept of Oncology
Bergen, Norway, N-5021
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
Study Chair: Per E Lonning, MD PhD Section of Oncology, Institute of Medicine, University of Bergen, Haukeland University Hospital
  More Information

Responsible Party: Per Eystein Lonning, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT00496795     History of Changes
Other Study ID Numbers: Ethics committee 079.06  NSD 14918  14918 
Study First Received: July 3, 2007
Last Updated: May 18, 2016
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
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Epirubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 23, 2016