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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Cyclophosphamide Drug: Methotrexate Drug: 5-Fluorouracil Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2002
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: 1
Drug: Docetaxel

Experimental: 2
Cyclophosphamide + Methotrexate + 5-fluorouracil
Drug: Cyclophosphamide

Drug: Methotrexate

Drug: 5-Fluorouracil

Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 18 months ]
  2. toxicity [ Time Frame: 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  • 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.

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): NCT00193011

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

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Responsible Party: Denise A. Yardley, M.D., Sarah Cannon Research Institute Identifier: NCT00193011     History of Changes
Other Study ID Numbers: SCRI BRE 41
GIA 11169
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors