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
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: Cyclophosphamide
Drug: Methotrexate
Drug: 5-Fluorouracil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2002
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Docetaxel
Drug: Docetaxel
Docetaxel
Other Name: Docetaxel
Experimental: 2
Cyclophosphamide + Methotrexate + 5-fluorouracil
Drug: Cyclophosphamide
Cyclophosphamide
Other Name: Cyclophosphamide
Drug: Methotrexate
Methotrexate
Other Name: Methotrexate
Drug: 5-Fluorouracil
5-Fluorouracil
Other Name: 5-Fluorouracil

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193011

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

No publications provided

Responsible Party: Denise A. Yardley, M.D., Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00193011     History of Changes
Other Study ID Numbers: SCRI BRE 41, GIA 11169
Study First Received: September 12, 2005
Last Updated: May 2, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Methotrexate
Docetaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014