Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Mitogens; Trastuzumab

Criteria

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.