Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Drug: 5-fluoruracilDrug: Granulocyte-colony stimulating growth factor
- Registration Number
- NCT01985724
- Lead Sponsor
- Hellenic Oncology Research Group
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 650
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A 5-fluoruracil FEC -\> TXT A Granulocyte-colony stimulating growth factor FEC -\> TXT B Granulocyte-colony stimulating growth factor Docetaxel/Cyclophosphamide (TC) A Docetaxel FEC -\> TXT A Cyclophosphamide FEC -\> TXT A Epirubicin FEC -\> TXT B Docetaxel Docetaxel/Cyclophosphamide (TC) B Cyclophosphamide Docetaxel/Cyclophosphamide (TC)
- Primary Outcome Measures
Name Time Method 3-year disease-free survival 3 years
- Secondary Outcome Measures
Name Time Method Overall survival 3 years Recurrence rate Relapses by the time of 3-years follow up
Trial Locations
- Locations (10)
"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
Air Forces Military Hospital of Athens
🇬🇷Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
🇬🇷Piraeus, Greece
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
🇬🇷Athens, Greece
401 Military Hospital of Athens
🇬🇷Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
🇬🇷Larissa, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
🇬🇷Alexandroupolis, Greece
University Hospital of Crete
🇬🇷Heraklion, Crete, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
🇬🇷Thessaloniki, Greece