Phase II Study With Trastuzumab + Paclitaxel in Locally Advanced HER2+ Tumors or Epirubicin + Taxotere in HER2- Tumors

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Prospective, monoinstitutional, phase II study. Patients with HER 2 positive locally advanced breast cancer will be treated with 3 initial cycles (12 weeks) of trastuzumab plus paclitaxel and then if responding further 12 weeks and then with surgical resection, patients with HER2 negative breast carcinoma will be treated with 4 cycles (12 weeks) of epirubicin and taxotere. If responding 4 more cycles (12 weeks). Patients progressing will be treated depending on physician's and patient's preference

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro di Riferimento Oncologico - Aviano
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Epirubicin; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically proven breast carcinoma evaluated for HER 2 status and immune status

• Locally advanced carcinoma (UICC stage II-III)

• Age < 70 years

• measurable lesions

• ECOG Performance Status 0-2

• Life expectancy > 3 months

• Adequate bone marrow and hepatic functions

• Creatinine Clearance > 40 ml/min

• Written informed consent

• Patients must be accessible for treatment and follow up.

Exclusion Criteria:

• Prior chemotherapy or hormonal treatments

• Brain metastases.

• Past or current history of neoplasm other than curatively treated.

• Concurrent treatment with other experimental drugs.

• Left Ventricular Ejection Fraction (LVEF) <50 %

• History of significant neurological or psychiatric disorders.