Predictors for Response to Dose-dense Docetaxel and Epirubicin Breast Cancer (MEDOBREC)
Molecular markers predicting response to dose dense chemotherapy with epirubicin and docetaxel in sequence for locally advanced breast cancer
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
|Stage III Breast Cancer AJCC V7||Other: epirubicin/docetaxel sequential||Phase 2|
|Study Design:||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.|
- To evaluate predictive factors to sequential dose-dense therapy with epirubicin followed by docetaxel in primary locally advanced breast cancer. [ Time Frame: 10 years ]
- To evaluate overall response to this dose dense sequential therapy treatment. [ Time Frame: 10 years ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||May 2026|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00496795
|Dept of Oncology|
|Bergen, Norway, N-5021|
|Study Chair:||Per E Lonning, MD PhD||Section of Oncology, Institute of Medicine, University of Bergen, Haukeland University Hospital|