Predictors for Response to Dose-dense Docetaxel and Epirubicin Breast Cancer (MEDOBREC)
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|ClinicalTrials.gov Identifier: NCT00496795|
Recruitment Status : Active, not recruiting
First Posted : July 4, 2007
Last Update Posted : October 30, 2017
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
|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)|
|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|
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)
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): 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|