Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer
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.Safety
and tolerability assessed by number of grade 4 toxicities and hospitalizations
Inclusion Criteria:
- HER-2 overexpressing breast cancer
- Clinical stage 2-3B
- Normal ejection fraction
Exclusion Criteria:
- Metastatic disease
- Low ejection fraction
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Patients With Pathologic Complete Response (pCR)
Outcome Description:
pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.
Outcome Time Frame:
determined at the time of surgery which is approximately 16 weeks from the beginning of treatment
Safety Issue:
No
Principal Investigator
Judith Hurley
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Miami
Authority:
United States: Institutional Review Board
Study ID:
SCCC 2004-064
NCT ID:
NCT00232479
Start Date:
September 2005
Completion Date:
June 2008
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Jackson Memorial Hospital | Miami, Florida 33136 |
