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

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. Identifier: NCT00193115
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 4, 2010
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Doxorubicin Drug: Cyclophosphamide Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Treatment-related toxicities

Secondary Outcome Measures :
  1. Overall response rate
  2. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193115

Sponsors and Collaborators
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
Principal Investigator: Denise A. Yardley, MD SCRI Development Innovations, LLC

Publications of Results:
Responsible Party: Denise A. Yardley, M.D., Sarah Cannon Research Institute Identifier: NCT00193115     History of Changes
Other Study ID Numbers: SCRI BRE 69
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 4, 2010
Last Verified: January 2009

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors