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Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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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 HospitalMiami, Florida  33136