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

NCT ID: NCT00193011

Last Updated: 2011-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2004-08-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Docetaxel

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel

2

Cyclophosphamide + Methotrexate + 5-fluorouracil

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide

Methotrexate

Intervention Type: DRUG

Methotrexate

5-Fluorouracil

Intervention Type: DRUG

5-Fluorouracil

Interventions

Docetaxel

Docetaxel

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide

Intervention Type: DRUG

Methotrexate

Methotrexate

Intervention Type: DRUG

5-Fluorouracil

5-Fluorouracil

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Sarah Cannon Research Institute

Principal Investigators

Denise Yardley, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Other Identifiers

GIA 11169

Identifier Type: -

Identifier Source: secondary_id

SCRI BRE 41

Identifier Type: -

Identifier Source: org_study_id