DDP
Molecular Markers Predictive Response to Dose Dense Chemotherapy With Epirubicin and Docetaxel in Sequences for Locally Advanced Breast Cancer.
Sponsor study identifier
Secondary identifiers
OTHER · Helse Vest IKT
interventional
100
1 country
1
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Actual (reported)Study Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Molecular markers predicting response to dose dense chemotherapy with epirubicin and docetaxel in sequence for locally advanced breast cancer Protocol summary. Principal Investigator Hans P. Eikesdal, Professor, Dept. of Oncology, Haukeland University Hospital \& Dept. of Clinical Science, University of Bergen Project leader: Professor Per Eystein Lønning, Dept. of Oncology, Haukeland University Hospital \& Dept. of Clinical Science, University of Bergen Collaborators. Dept of Surgery - Responsible: Turid Aas, Consultant Surgeon Participants. Dept of Oncology 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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 3, 2007
Actual (reported)July 4, 2007
Actual (reported)September 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 2016
Actual (reported)May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To correlate molecular parameters to objective response to each of the 2 regimens applied.
To correlate molecular parameters to objective response to sequential dose-dense therapy with epirubicin followed by docetaxel in primary locally advanced breast cancer.
10 years
To correlate molecular parameters to relapse-free and overall survival.
10 years
To identify and explore characteristics of epithelial and mesenchymal stem cells isolated in tumor tissue and bone marrow
10 years
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.
Epirubicin 60 mg/m2, q2w 4 cycles. Followed by docetaxel 100 mg/m2 q2w 4 cycles
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
epirubicin/docetaxel sequential
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordDept of Oncology
Bergen, N-5021, Norway
Hatletvedt ND, Engebrethsen C, Geisler J, Geisler S, Aas T, Lonning PE, Gansmo LB, Knappskog S. The impact of functional MDM2-polymorphisms on neutrophil counts in breast cancer patients during neoadjuvant chemotherapy. BMC Cancer. 2025 Feb 20;25(1):308. doi: 10.1186/s12885-025-13675-2.
Venizelos A, Engebrethsen C, Deng W, Geisler J, Geisler S, Iversen GT, Aas T, Aase HS, Seyedzadeh M, Steinskog ES, Myklebost O, Nakken S, Vodak D, Hovig E, Meza-Zepeda LA, Lonning PE, Knappskog S, Eikesdal HP. Clonal evolution in primary breast cancers under sequential epirubicin and docetaxel monotherapy. Genome Med. 2022 Aug 11;14(1):86. doi: 10.1186/s13073-022-01090-2.
Per E Lonning, MD PhD
Section of Oncology, Institute of Medicine, University of Bergen, Haukeland University Hospital
First Submitted
July 3, 2007
First Posted
July 4, 2007
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Contact the study team to confirm eligibility.
May 2016
Actual (reported)Study Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 29, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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