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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Docetaxel; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Docetaxel	Drug: Docetaxel; Docetaxel
Experimental: 2; Cyclophosphamide + Methotrexate + 5-fluorouracil	Drug: Cyclophosphamide; Cyclophosphamide; Drug: Methotrexate; Methotrexate; Drug: 5-Fluorouracil; 5-Fluorouracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease-free survival	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	18 months
toxicity	18 months

Collaborators and Investigators

• Sponsor: SCRI Development Innovations, LLC
• Collaborators: Aventis Pharmaceuticals
• Investigators: Principal Investigator: Denise Yardley, MD, SCRI Development Innovations, LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): August 1, 2004
• Study Completion (Actual): August 1, 2004

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): May 3, 2011
• Last Update Submitted That Met QC Criteria: May 2, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Docetaxel; Cyclophosphamide; Fluorouracil; Methotrexate
• Other Study ID Numbers: SCRI BRE 41; GIA 11169