Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer - Full Text View

Sponsors and Collaborators:	University of Miami Aventis Pharmaceuticals
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00232479

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: carboplatin, docetaxel, herceptin	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Docetaxel Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer

Further study details as provided by University of Miami:

Primary Outcome Measures:

pathologic complete response [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

safety and tolerability [ Designated as safety issue: Yes ]

Enrollment:	48
Study Start Date:	September 2005
Study Completion Date:	June 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

carboplatin AUC 6 IV every other week x 4, herceptin 2 mg/kg IV every week x 10, docetaxel 75 mg/m2 IV every other week x 4

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HER-2 overexpressing breast cancer
Clinical stage 2-3B
Normal ejection fraction

Exclusion Criteria:

Metastatic disease
Low ejection fraction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232479

Locations

United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Aventis Pharmaceuticals

Investigators

Principal Investigator:

Judith Hurley

University of Miami

More Information

Responsible Party:	University of Miami ( Judith Hurley )
Study ID Numbers:	SCCC 2004-064
Study First Received:	September 30, 2005
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00232479
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Trastuzumab

Breast Neoplasms
Carboplatin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009