Spots Global Cancer Trial Database for Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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