IU Simon Cancer Center Researchers' Breast Cancer Trials Offer Recognized Potential To Improve Treatment, Survival

Main Category: Breast Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 28 Nov 2008 - 0:00 PDT

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Two breast cancer clinical trials led by Indiana University Melvin and Bren Simon Cancer Center researchers are among 13 selected by a national panel as having the greatest potential to improve treatment and survival.

The Coalition of Cancer Cooperative Groups (CCCG) recently convened a panel of breast cancer experts who included clinical trials led by Kathy Miller, M.D., and Victoria Champion, R.N., D.N.S., among the 13 promising phase III breast cancer research studies.

The 13 studies were selected from more than 515 active U.S. phase III trials. The IU Simon Cancer Center and M.D. Anderson Cancer Center were the only cancer centers in the nation to have two studies selected.

"We are pleased these two studies have been recognized," said IU Simon Cancer Center Director Stephen D. Williams, M.D., the HH Gregg Professor of Oncology and associate dean for research at the Indiana University School of Medicine. "At any given time, we have more than 100 clinical studies underway that hold promise for patients at the IU Simon Cancer Center."

Dr. Miller is the principal investigator of "A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer" and Dr. Champion leads "Quality of Life in Younger Breast Cancer Survivors." (See below for specific information on each study.)

The CCCG's Scientific Leadership Council (SLC) in Breast Cancer outlined its consensus - "Research Priorities in Breast Cancer: Recommendations of the Scientific Leadership Council in Breast Cancer of the Coalition of Cancer Cooperative Groups" - at a meeting of physicians, researchers, patient advocates, government and industry representatives in Dallas Sept. 12-13, and urged physicians to enroll as many of their eligible patients into the trials as possible.

Rapid enrollment and timely completion of these 13 studies can quicken the pace of diagnostic and treatment advances by resolving clinical questions such as:

- How to predict the impact of biological effects of chemopreventive agents with the development and validation of new, clinically relevant biomarkers

- How to design, select and afford individualized cancer therapy in an era of escalating costs for biologic treatments

- How, when and whether to use chemotherapy in breast cancer treatment for some patients

- How to best incorporate novel approaches, including biophosphonates in breast cancer treatment to reduce the risk of bone metastases

- How best to address the growing issue of long-term neurotoxic and cognitive side effects in breast cancer survivors

- How to design clinical trials that can be completed more efficiently, including randomized discontinuation trials or "adaptive" trial designs that require fewer patients and/or shorter study duration

According to the American Cancer Society, breast cancer is the most common cancer among women in the United States, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer. About 182,460 women in the United States will be found to have invasive breast cancer in 2008; about 40,480 women will die from the disease this year.

Research has shown that only about 15 percent of all breast cancer patients are aware of clinical trials at the time of their diagnosis, according to the CCCG.

The CCCG's TrialCheck is an Internet-based system of all federally registered cancer studies that links patients to clinical trial information. It can be accessed at http://www.CancerTrialsHelp.org.

Other helpful tools include the IU Simon Cancer Center's clinical trial database (http://www.cancer.iu.edu/cancer/trials) as well as databases from the American Cancer Society and the National Cancer Institute.

Fact Sheet

Study name: "A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer"

Principal Investigator: Kathy Miller, M.D., associate professor of medicine and the Sheila D. Ward Scholar at the IU School of Medicine

What treatment will be given in the study? In the study, patients will receive either standard chemotherapy alone, standard chemotherapy with bevacizumab in some cycles or standard chemotherapy with bevacizumab in all cycles followed by bevacizumab alone.

What types of patients will take part in the study? Patients with lymph node positive and high-risk lymph node negative breast cancer.

How many patients will take part in the study? 4,950

What is the current status of the trial? The study opened in November 2007 and is actively recruiting patients. The planned accrual timeframe for the study is about two years.

Where is the trial taking place? At participating hospitals, cancer centers, and oncology practices in the United States. For more information, visit the Coalition of Cancer Cooperative Groups' TrialCheck at http://www.CancerTrialsHelp.org.

Study name: "Quality of Life in Younger Breast Cancer Survivors"

Principal Investigator: Dr. Victoria Champion, Mary Margaret Walther Professor of Nursing and Edward W. and Sarah Stam Cullipher Chair, IU School of Nursing

What research question will this study answer? The study will answer whether there are unique quality of life issues for younger breast cancer survivors and their partners compared to older breast cancer survivors.

What treatment will be given in the study? No treatment will be given in the study. Breast cancer survivors and their partners and/or acquaintances will complete a survey and a phone interview.

What types of patients will take part in the study? Female breast cancer survivors between the ages of 18 and 45 at diagnosis (younger group) and ages 55 to 70 at diagnosis (older group) who participated in studies C9741, E1199, E2197, and N9831 or received a comparable treatment regimen not on these studies.

How many patients will take part in the study? 1,070 survivors

What is the current status of the trial? The study opened in October 2005 and is actively recruiting patients. The planned accrual timeframe for the study is three years.

Where is the trial taking place? At participating hospitals, cancer centers, and oncology practices in the United States. For more information, visit the Coalition of Cancer Cooperative Groups' TrialCheck at http://www.CancerTrialsHelp.org.

Indiana University Melvin and Bren Simon Cancer Center