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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193011

Enrollment

150

Registered

2005-09-19

Start date

2002-03-31

Completion date

2004-08-31

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

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.

Interventions

DRUGDocetaxel

Docetaxel

DRUGCyclophosphamide

Cyclophosphamide

DRUGMethotrexate

Methotrexate

DRUG5-Fluorouracil

5-Fluorouracil

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
disease-free survival	18 months

Secondary

Measure	Time frame
overall survival	18 months
toxicity	18 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026