Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer

This study has been completed.

First Received: September 12, 2005 Last Updated: January 15, 2009 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute Aventis Pharmaceuticals
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193115

Purpose

This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node positive and high risk breast cancer

Condition	Intervention	Phase
Breast Cancer	Drug: Docetaxel Drug: Doxorubicin Drug: Cyclophosphamide	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Doxorubicin Doxorubicin hydrochloride Myocet Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Pilot Trial of Dose-Dense Docetaxel Followed by Doxorubicin Plus Cyclophosphamide (T-AC) Given as Adjuvant or Neoadjuvant Treatment for Women With Node Positive or High-Risk Primary Breast Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Treatment-related toxicities

Secondary Outcome Measures:

Overall response rate
Overall survival

Estimated Enrollment:	32
Study Start Date:	March 2004
Study Completion Date:	January 2009
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Detailed Description:

Upon determination of eligibility, patients will receive:

Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery

Adjuvant patients will enter the study after surgery and receive Docetaxel+ Doxorubicin + Cyclophosphamide. Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy. Patients with positive estrogen and/or progesterone receptors will begin anti-estrogen therapy after the last course of chemotherapy.

Eligibility

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

Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Histologically proven breast cancer
Females, age greater than 18 years
Ability to perform activites of daily living with minimal assistance
Normal cardiac function
Adequate bone marrow, liver and kidney
Signed informed consent prior to beginning specific protocol procedures

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Prior systemic anticancer therapy for breast cancer
Prior anthracycline or taxane based chemotherapy for any malignancy
Pregnant or breast-feeding women.
Pre-existing moderate to severe motor or sensory neurotoxicity
Other serious illness or medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193115

Sponsors and Collaborators

Sarah Cannon Research Institute

Aventis Pharmaceuticals

Investigators

Principal Investigator:

Denise A. Yardley, MD

Sarah Cannon Research Institute

More Information

No publications provided

Responsible Party:	Sarah Cannon Research Institute ( Denise A. Yardley, M.D. )
Study ID Numbers:	SCRI BRE 69, 11251
Study First Received:	September 12, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00193115 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Immunologic Factors
Adjuvants, Immunologic
Breast Neoplasms
Cyclophosphamide
Immunosuppressive Agents
Doxorubicin

Docetaxel
Anti-Bacterial Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Breast Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Skin Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Cyclophosphamide
Antibiotics, Antineoplastic
Immunosuppressive Agents
Doxorubicin

Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009