New Clinical Trial Looks at Reducing Recurrence of Aggressive Breast Cancer

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Yesterday, University Hospitals (UH) Case Medical Center announced its physician-scientists are exploring a new method to potentially prevent recurrence of an early stage, aggressive type of breast cancer in a first-of-its-kind clinical trial.

The pilot study will be conducted by Joe Baar, MD, Director of Breast Cancer Research at UH Case Medical Center's Seidman Cancer Center, and is recruiting patients with HER-2 neu+ breast cancer.

HER2, which is also called HER2/neu, and HER-2, is the acronym for human epidermal growth factor receptor 2. When breast cancer is tested for HER2 status, the results will be graded as positive or negative. If the results are graded as HER2 positive, that means that the HER2 genes are over-producing the HER2 protein, and that those cells are growing rapidly and creating the cancer.

It is estimated approximately 1 in 5 breast cancers are HER2 positive. Patients with this aggressive form of breast cancer typically have a higher recurrence rate of nearly 25% following initial treatment. This new study aims to improve outcomes through performing bone marrow biopsies to identify if patients' cancer has spread and adding an additional cancer-targeting drug to standard therapy.

In addition to being more aggressive, HER2-positive breast cancers tend to be less responsive to hormone treatment. However, treatments that specifically target HER2 are very effective.

HER2 specific treatments include:

  1. Trastuzumab (Herceptin) which specifically targets HER2 and decreases the risk of recurrence. Trastuzumab is usually well tolerated, but it does have some potential side effects, such as congestive heart failure and allergic reaction.
  2. Lapatinib (Tykerb) is also a HER2-specific drug. It may be effective for HER2-positive breast cancer that don't respond to trastuzumab

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In addition to the HER2 specific treatment, patients are given other chemotherapy regimens which may include doxorubicin (Adriamycin), aromatase inhibitor or tamoxifen.

"This study has the potential to change the standard of care for women with this type of breast cancer, which tends to spread very quickly," says Dr. Baar, who is also Associate Professor of Medicine at Case Western Reserve University School of Medicine. "A small number of HER-2 neu+ breast cancer patients do not do well following standard therapy. We are hoping to identify these high-risk patients and stop the cancer before it progresses to other parts of the body."

Traditional imaging, such as CT scans and bone scans, does not detect these microscopic metastases, which are small numbers of cancer cells that have spread from the breast to other areas of the body such as the bone marrow. Therefore, patients who are found to have such micrometastases in the bone marrow will receive the cancer-fighting drug Bevacizumab (Avastin) to rid the bone marrow of the micrometastases. The study is funded by Genentech through University Hospitals Case Medical Center.

"This important trial has the potential to really help this subset of women with HER-2 neu+ breast cancer who have a high rate of recurrence," says Stanton Gerson, MD, Director of the UH Seidman Cancer Center and the Case Comprehensive Cancer Center. "This innovative trial has the potential to lay the groundwork for a new standard of care for women with this aggressive form of breast cancer."

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For more information about the study, call the UH Seidman Cancer Center at 800-641-2422.

Source
UH Seidman Cancer Center Press Release, March 8, 2011

HER2/neu and Diagnosis Information

HER2-positive breast cancer: What is it?

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