Docetaxel is a chemotherapy drug commonly used to treat women with breast cancer. However, our understanding of how well older women tolerate and respond to the drug is limited. This study is a first attempt to examine that issue.

What are the objectives of this clinical trial?

This study will assess the effectiveness, toxicity, and patient quality of life following treatment with Docetaxel (Taxotere).

What is the study design?

Sixty patients, age 70 or older, and twenty patients under the age of 60 will be enrolled. Patients will receive a one-hour intravenous infusion of Docetaxel every 21 days. They will be followed for three years to assess the efficacy of the treatment, side effects, and quality of life.

What are the eligibility criteria?

A woman is eligible to enroll in this study if she meets all of the following criteria:

Pathologically confirmed breast cancer;
70 years or older; or less than 60 years;
Measurable disease w/ distantly metastatic breast cancer;
Chest x-ray;
Serum creatinine and bilirubin <= IULN;
SGOT/SGPT <= 1.5 x IULN;
Alkaline phos <= IULN;
AGC >= 1,500/ul;
Hemoglobin >= 9gm/dl;
Platelets >= 100,000/ul;
No prior chemo for advanced, recurrent or metastatic disease;
Prior adjuvant or neoadjuvant therapy OK;
Prior hormonal therapy OK;
No known brain or CNS metastases;
Recovered from effects of prior radiation therapy or surgery;
Pharmacokinetic sampling;
No known HIV.

Who is conducting the trial?

The Southwest Oncology Group (SWOG) is conducting the trial through a grant from the National Cancer Institute. SWOG is a cancer research cooperative group that includes nearly 4,000 cancer researchers at 238 institutions in the U.S. and Canada. The mission of the group is to improve the lives of cancer patients through research into the cause of cancer, and the development of effective treatments.

Texas Locations for this trial

San Antonio

Brooke Army Medical Center, Fort Sam Houston.
Contact Mitchell A. Garrison, MD
210-916-0504
e-mail

University of Texas Health Science Center at San Antonio
Contact Geoffrey R. Weiss, MD
210-617-5120
e-mail

Audie L. Murphy Veterans Hospital
Contact Geoffrey R. Weiss, MD
210-617-5300
e-mail

Temple

CCOP - Scott and White Hospital
Contact Lucas Wong, MD
254-724-1053

Veterans Affairs Medical Center
Contact Phalguni Mukhopadhyay, MD
254-778-4811 ext. 4809

Houston Area

Veterans Affairs Medical Center - Houston
Contact Gauri Varadhachary, MD
713-791-1414 Ext. 5340

University of Texas Medical Branch, Galveston
Contact Robert P. Whitehead, MD
409-772-1164
e-mail

More Information

For more information please visit SWOG's clinical trial page, the National Cancer Institute's clinical trials page, or phone the Southwest Oncology Group Operations Office at 210-667-8808 and ask for information on trial S0029.

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Completion of the Theratope Vaccine Trial for Metastatic Breast Cancer - A statement from National Breast Cancer Coalition Fund (NBCCF)

For the past several years, NBCCF has partnered with the Canadian company Biomira on the pivotal Phase III trial of the Theratope vaccine for women with metastatic breast cancer. Theratope mimics a protein expressed by cancer cells, which may activate the immune system to recognize and selectively attack cancer. On June 16, 2003, Biomira announced that the Theratope vaccine did not meet the predetermined endpoints of improved time to disease progression or overall survival for the women enrolled. One pre-stratified subset within the treatment group, women on hormonal treatment following chemotherapy, is going to be evaluated further to examine the possibility of a survival benefit. It is not possible to determine whether such a benefit exists based upon this first analysis of the data alone.

NBCCF is disappointed that Theratope did not improve time to disease progression or survival for the women enrolled in this trial. Clinical trials are intended to test unproven treatments, and a positive treatment result is never a certainty. Ultimately, the success of a trial is determined by its ability to measure a treatment's safety and clinical benefit. This was a well-designed, well-conducted trial that is answering a very important treatment question about the appropriateness of Theratope for metastatic breast cancer. The information gathered in this trial can be used to inform future trials of immunotherapy for breast cancer.

The Theratope trial is a valuable model for the power of collaboration between advocates and industry. NBCCF advocates have remained involved in all aspects of this trial, from design and oversight to patient accrual. Advocate involvement has helped to make this a trial that accrued rapidly, proceeded safely, and obtained concrete answers in a timely fashion. NBCCF believes that clinical trials are critical in the fight against breast cancer, and is proud of the hard work and tremendous success of its advocates in advancing this cause through our collaborations.

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