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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by University of Bergen
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 16, 2012
Last verified: May 2012
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496795

Contacts
Contact: Gun Anker, MD PhD +47 55 97 20 10 gun.anker@helse-bergen.no
Contact: Hans P Eikesdal, MD 004755972010 hans.petter.eikesdal@helse-bergen.no

Locations
Norway
Dept of Oncology Recruiting
Bergen, Norway, N-5021
Contact: Gun Anker, MD    004755972010    gun.anker@helse-bergen.no   
Contact: Hans P Eikesdal, MD    004755972010    hans.petter.eikesdal@helse-bergen.no   
Principal Investigator: Per E Lønning, Professor         
Sub-Investigator: Gun B Anker, MD         
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

No publications provided

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
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
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014