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
Sponsor:
University of Bergen
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
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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
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 May 21, 2013