Breast Cancer Clinical Trial
Official title:
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
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
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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