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

SCRI Development Innovations

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: 5-Fluorouracil

Drug: Docetaxel

Drug: Cyclophosphamide

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193011

SCRI BRE 41

GIA 11169

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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/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.