- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01985724
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
Study Overview
Status
Conditions
Detailed Description
Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. At least five large randomized clinical trials demonstrated that the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an anthracycline-based regimen resulted in superior clinical outcome for women with node positive or high risk node-negative early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer.
Data from at least one trial suggest that four cycles of a non-anthracycline but taxane-containing adjuvant regimen (docetaxel plus cyclophosphamide) provide outcomes that are at least as good, if not better than four cycles of doxorubicin/cyclophosphamide combination.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Alexandroupolis, Greece
- University General Hospital of Alexandroupolis, Dep of Medical Oncology
-
Athens, Greece
- "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
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Athens, Greece
- "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
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Athens, Greece
- "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
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Athens, Greece
- 401 Military Hospital of Athens
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Athens, Greece
- Air Forces Military Hospital of Athens
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Larissa, Greece
- State General Hospital of Larissa, Dep of Medical Oncology
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Piraeus, Greece
- "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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Thessaloniki, Greece
- "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
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Crete
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Heraklion, Crete, Greece, 71110
- University Hospital of Crete
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
FEC -> TXT
|
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
Other Names:
ARM A: Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Names:
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
Other Names:
ARM A: 5-fluoruracil 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Names:
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
|
Experimental: B
Docetaxel/Cyclophosphamide (TC)
|
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
Other Names:
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
Other Names:
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3-year disease-free survival
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 3 years
|
3 years
|
Recurrence rate
Time Frame: Relapses by the time of 3-years follow up
|
Relapses by the time of 3-years follow up
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Adjuvants, Immunologic
- Antibiotics, Antineoplastic
- Docetaxel
- Cyclophosphamide
- Fluorouracil
- Epirubicin
- Lenograstim
- Mitogens
Other Study ID Numbers
- CT/07.17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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