Overview

Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
Female
Summary
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Miami
Collaborator:
Aventis Pharmaceuticals
Treatments:
Carboplatin
Docetaxel
Trastuzumab
Criteria
Inclusion Criteria:

- HER-2 overexpressing breast cancer

- Clinical stage 2-3B

- Normal ejection fraction

Exclusion Criteria:

- Metastatic disease

- Low ejection fraction