Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk 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: NCT00193011
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 3, 2011
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC

September 12, 2005
September 19, 2005
May 3, 2011
March 2002
August 2004   (Final data collection date for primary outcome measure)
disease-free survival [ Time Frame: 18 months ]
disease-free survival
Complete list of historical versions of study NCT00193011 on Archive Site
  • overall survival [ Time Frame: 18 months ]
  • toxicity [ Time Frame: 18 months ]
  • overall survival
  • toxicity
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Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer
A Randomized Multicenter Trial Comparing Weekly Docetaxel and CMF in the Adjuvant Treatment of Women With High-Risk Breast Cancer Who Are > 65 Years Old or Are Not Candidates for Anthracycline-Based Adjuvant Therapy
This trial will evaluate the effectiveness of standard adjuvant treatment with CMF chemotherapy versus treatment with weekly docetaxel in patients with high-risk breast cancer who are 65 years of age and older or are poor candidates for anthracycline-containing regimens. This CMF regimen has decreased dose intensity and may be slightly less active in patients with metastatic breast cancer; however, the patient population in this trial has tolerated more intensive CMF regimens poorly in other trials.

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

  • Docetaxel
  • Cyclophosphamide + Methotrexate + 5-fluorouracil

This is not a blinded study so both the patient and the investigator will know which treatment has been assigned.

Chemotherapy will be followed by breast and/or regional radiotherapy in appropriate patients, and by hormone therapy with tamoxifen for 5 years in patients who are estrogen-receptor positive. Patients who are considered poor candidates to receive tamoxifen may receive hormonal therapy with anastrazole.

Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
  • Drug: Cyclophosphamide
  • Drug: Methotrexate
  • Drug: 5-Fluorouracil
  • Experimental: 1
    Intervention: Drug: Docetaxel
  • Experimental: 2
    Cyclophosphamide + Methotrexate + 5-fluorouracil
    • Drug: Cyclophosphamide
    • Drug: Methotrexate
    • Drug: 5-Fluorouracil
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2004
August 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

  • Female patients with adenocarcinoma of the breast confirmed by biopsy
  • Age 65 or older
  • Under age 65 must have significant medical illness, or general frailty
  • Adequate bone marrow, liver or kidney function
  • Normal heart function
  • Less than 84 days from mastectomy/lumpectomy or axillary dissection
  • Signed consent obtained prior to initiation of any study procedures

Exclusion Criteria:

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

  • Received neo-adjuvant therapy
  • Primary tumor is locally advanced at diagnosis
  • Received prior chemotherapy within five years
  • Received previous radiation therapy within 5 years
  • Peripheral neuropathy

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)
Contact information is only displayed when the study is recruiting subjects
Not Provided
GIA 11169
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Denise A. Yardley, M.D., Sarah Cannon Research Institute
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
Principal Investigator: Denise Yardley, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
May 2011

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