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

This study has been completed.
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC Identifier:
First received: September 12, 2005
Last updated: August 3, 2010
Last verified: January 2009
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by SCRI Development Innovations, LLC:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00193115

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

Additional Information:
Responsible Party: Denise A. Yardley, M.D., Sarah Cannon Research Institute Identifier: NCT00193115     History of Changes
Other Study ID Numbers: SCRI BRE 69
Study First Received: September 12, 2005
Last Updated: August 3, 2010

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 processed this record on April 28, 2017