Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer
A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-supported Sequential Administration of FE75C Followed by Docetaxel Versus Docetaxel/Cyclophosphamide Doublet as Adjuvant Chemotherapy in Women With HER-2 Negative, Axillary Lymph Node Positive Breast Cancer
1 other identifier
interventional
650
1 country
10
Brief Summary
In this trial investigators propose to assess the dose dense, G-CSF supported sequential administration of 4 cycles of FEC followed by 4 cycles of docetaxel versus 6 cycles of docetaxel/cyclophosphamide as adjuvant chemotherapy in women with HER-2 negative, axillary lymph node positive breast cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Oct 2007
Typical duration for phase_3 breast-cancer
10 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
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 9, 2013
CompletedFirst Posted
Study publicly available on registry
November 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 14, 2014
May 1, 2014
6.2 years
November 9, 2013
May 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year disease-free survival
3 years
Secondary Outcomes (2)
Overall survival
3 years
Recurrence rate
Relapses by the time of 3-years follow up
Study Arms (2)
A
ACTIVE COMPARATORFEC -\> TXT
B
EXPERIMENTALDocetaxel/Cyclophosphamide (TC)
Interventions
ARM A: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 2 weeks for 4 cycles ARM B: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 3 weeks for 6 cycles
ARM A: Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
ARM A: Cyclophosphamide 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles ARM B: Cyclophosphamide 600 mg/m2 IV push on day 1 every 3 weeks for 6 cycles
ARM A: 5-fluoruracil 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Eligibility Criteria
You may qualify if:
- Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
- Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
- Tumor involvement of at least one axillary lymph node
- Absence of any clinical or radiological evidence of local or metastatic disease
- Premenopausal or postmenopausal women aged 18-75 years old
- Adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3)
- Adequate liver (bilirubin \<1.0 times upper limit of normal and SGOT/SGPT \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl)
- Adequate cardiac function (LVEF\>50%)
- Written informed consent
You may not qualify if:
- Positive pregnancy test.
- Psychiatric illness or social situation that would preclude study compliance.
- Other concurrent uncontrolled illness.
- Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
- Previous history of other invasive malignancy other than non-melanomatous skin cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hellenic Oncology Research Grouplead
- University Hospital of Cretecollaborator
Study Sites (10)
University Hospital of Crete
Heraklion, Crete, 71110, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Related Publications (1)
Mavroudis D, Matikas A, Malamos N, Papakotoulas P, Kakolyris S, Boukovinas I, Athanasiadis A, Kentepozidis N, Ziras N, Katsaounis P, Saloustros E, Georgoulias V; Breast Cancer Investigators of the Hellenic Oncology Research Group (HORG), Athens, Greece. Dose-dense FEC followed by docetaxel versus docetaxel plus cyclophosphamide as adjuvant chemotherapy in women with HER2-negative, axillary lymph node-positive early breast cancer: a multicenter randomized study by the Hellenic Oncology Research Group (HORG). Ann Oncol. 2016 Oct;27(10):1873-8. doi: 10.1093/annonc/mdw274. Epub 2016 Aug 8.
PMID: 27502729DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dimitris Mavrudis, MD
University Hospital of Crete
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2013
First Posted
November 15, 2013
Study Start
October 1, 2007
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 14, 2014
Record last verified: 2014-05