Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel
ETCat01
Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer
1 other identifier
interventional
50
1 country
3
Brief Summary
The purpose of this study is to optimize results in neoadjuvant chemotherapy of local advanced primary breast cancer. Therefore patients become first 3 cycles of Epirubicin/Docetaxel followed by 3x Carboplatin/Docetaxel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2006
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 7, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedJanuary 15, 2010
January 1, 2010
2.3 years
September 7, 2007
January 14, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Determining pathologic complete remission under study treatment
28 days after last administration of chemotherapy
Secondary Outcomes (3)
Rate of breast conserving operations
28 days after administration of last chemotherapy
Response to treatment
28 days after last administration of chemotherapy
Determining the therapy associated toxicity
28 days after last administration of chemotherapy
Interventions
75 mg/m² Docetaxel (60 minutes i.v.) and 90 mg/m² Epirubicin (10-15 min i.v.) on day 1, 22, 42. After these 3 cycles 75 mg/m² Docetaxel (60 minutes i.v.) and Carboplatin AUC 5 (30 min i. v.) on day 63, 84, 105.
Eligibility Criteria
You may qualify if:
- histologically assured breast cancer
- age \>= 18 years
- bone marrow function: neutrophils \>= 1.5x109/l, platelets \>= 100x109/l, hemoglobin \>=6.2 mmol/l
- sufficient renal and liver function
- ECOG 0-2
- written informed consent
You may not qualify if:
- pregnant or nursing women
- distant metastases
- T2-Tumour \< 3cm and G1
- existing motoric or sensoric neurotoxicity \> Grade 2
- known hypersensitivity against Epirubicin or other anthracycline or against Carboplatin or other platin derivatives or against Docetaxel or against substances in the preparing solutions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Krankenhaus St. Elisabeth u. St. Barbara
Halle, Saxony-Anhalt, 06110, Germany
Klinikum Marienstift
Magdeburg, Saxony-Anhalt, 39110, Germany
Asklepios Krankenhaus Weissenfels
Weißenfels, Saxony-Anhalt, 06667, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dieter Lampe, Dr. med.
Asklepios Krankenhaus Weissenfels
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2007
First Posted
September 10, 2007
Study Start
May 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
January 15, 2010
Record last verified: 2010-01