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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193011
• Other study ID #: SCRI BRE 41
• Secondary ID: GIA 11169
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 2, 2011
• Start date: March 2002
• Est. completion date: August 2004

Study information

• Verified date: May 2011
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel
• Cyclophosphamide
Cyclophosphamide
• Methotrexate
Methotrexate
• 5-Fluorouracil
5-Fluorouracil

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		18 months	No
Secondary	overall survival		18 months	No
Secondary	toxicity		18 months	No