Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer
Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer
This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense
 docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive
 breast cancer overexpressing HER2
Anthracycline-containing regimens are recommended as adjuvant treatment for women with node
 positive breast cancer. In at least three large randomized clinical trials the addition or
 sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based
 regimen resulted in superior clinical outcome for women with node positive 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. Trastuzumab (anti-HER2 monoclonal antibody) in
 combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast
 cancer overexpressing HER2
Inclusion Criteria:

 -  Women with histologically-confirmed unilateral invasive ductal or lobular breast
 adenocarcinoma

 -  HER2/c-neu over expression should be documented by either immunohistochemistry (score
 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only
 if FISH/CISH positive

 -  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 (N0 with HER2/c-neu over
 expression are also eligible)

 -  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%). Normal electrocardiogram and absence of
 significant heart disease

 -  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.