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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: 5-Fluorouracil

• Registration Number: NCT00193011
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-03
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-02
• Last Update Posted: 2011-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	Docetaxel
2	Cyclophosphamide	Cyclophosphamide + Methotrexate + 5-fluorouracil
2	Methotrexate	Cyclophosphamide + Methotrexate + 5-fluorouracil
2	5-Fluorouracil	Cyclophosphamide + Methotrexate + 5-fluorouracil

Primary Outcome Measures

Name	Time	Method
disease-free survival	18 months

Secondary Outcome Measures

Name	Time	Method
overall survival	18 months
toxicity	18 months