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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193115
First Posted: September 19, 2005
Last Update Posted: August 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC
September 12, 2005
September 19, 2005
August 4, 2010
March 2004
June 2005   (Final data collection date for primary outcome measure)
Treatment-related toxicities
Same as current
Complete list of historical versions of study NCT00193115 on ClinicalTrials.gov Archive Site
  • Overall response rate
  • Overall survival
Same as current
Not Provided
Not Provided
 
Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer
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
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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
  • Drug: Doxorubicin
  • Drug: Cyclophosphamide
Not Provided
Yardley DA, Burris HA 3rd, Farley CP, Barton JH, Peacock NW, Spigel DR, Greco FA, Hainsworth JD. A phase II feasibility trial of dose-dense docetaxel followed by doxorubicin/cyclophosphamide as adjuvant or neoadjuvant treatment for women with node-positive or high-risk node-negative breast cancer. Clin Breast Cancer. 2008 Jun;8(3):242-8. doi: 10.3816/CBC.2008.n.027.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2009
June 2005   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00193115
SCRI BRE 69
11251
Not Provided
Not Provided
Not Provided
Denise A. Yardley, M.D., Sarah Cannon Research Institute
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
Principal Investigator: Denise A. Yardley, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP