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Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193011
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011

September 12, 2005
May 2, 2011
March 2002
August 2004   (final data collection date for primary outcome measure)
disease-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
disease-free survival
Complete list of historical versions of study NCT00193011 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • overall survival
  • toxicity
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
    Docetaxel
    Other Name: Docetaxel
  • Drug: Cyclophosphamide
    Cyclophosphamide
    Other Name: Cyclophosphamide
  • Drug: Methotrexate
    Methotrexate
    Other Name: Methotrexate
  • Drug: 5-Fluorouracil
    5-Fluorouracil
    Other Name: 5-Fluorouracil
  • Experimental: 1
    Docetaxel
    Intervention: Drug: Docetaxel
  • Experimental: 2
    Cyclophosphamide + Methotrexate + 5-fluorouracil
    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Methotrexate
    • Drug: 5-Fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
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.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193011
SCRI BRE 41, GIA 11169
Not Provided
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