Clinical Trial Will Test Effectiveness of Herceptin in Early-Stage Breast Cancer Patients Prior to Surgery (dateline December 17, 2001)
The drug Herceptin (generic name, trastuzumab) is currently used to treat women with advanced breast cancer whose cancer cells carry extra copies of the HER2 gene, which can make the disease particularly aggressive. Now, for the first time, researchers from the M.D. Anderson Cancer Center in Houston, Texas are recruiting women with early-stage breast cancer to enroll in a clinical trial that aims to determine the effectiveness of Herceptin prior to breast cancer surgery.The hope is that Herceptin will significantly shrink the womens breast tumors (so that less invasive surgery may be performed) or possibly even eliminate the cancer.
HER2 (also written HER2/neu) is a gene that, when functioning normally, has been found to be a key component in regulating cell growth. However, when the HER2 gene is altered, extra copies may be produced. This over-expression of HER2 causes increased cell growth and reproduction, often resulting in more aggressive breast cancer cells. It is estimated that between 25% and 30% of breast cancer patients carry, or overexpress, the HER2 gene. Herceptin is a drug treatment that targets breast cancer cells with extra HER2 copies and slows the growth and spread of these cells.
While Herceptin has been shown to be effective in advanced breast cancer patients, the M.D. Anderson clinical trial is the first to test Herceptin in women with early-stage breast cancer tumors before they undergo surgery. A total of 164 women with untreated breast tumors that overexpress the HER2 gene will be enrolled to undergo a combination of treatment with Herceptin and chemotherapy prior to breast cancer surgery.
We are initially studying Herceptin as an early-phase treatment in patients who have an unfavorable prognosis in beating their disease simply because of the makeup of their tumors' genes, said lead researcher Dr. Aman Buzhar, in an M.D. Anderson news release.With the addition of Herceptin to standard neoadjuvant chemotherapy regimen prior to surgery, we hope to downstage the size of the primary tumor, possibly reducing the need for a major breast surgery such as a mastectomy in favor of a less invasive surgery option. We also want to see if this combination decreases the risk of local recurrences.HER2-positive breast cancer is associated with a higher rate of cancer recurrence (i.e., the cancer is more likely to return after treatment).
During the clinical trial, all of the participants will undergo a chemotherapy regimen consisting of Taxol and a combination of 5-Fu, Epirubicin, and Cytoxan (FEC). In addition, some of the patients will also receive Herceptin.During this time, the women will receive mammograms and physical breast exams at an interval determined by the researchers.After the drug treatment is completed, all of the patients will undergo surgery to determine the size of their tumors. While most breast tumors shrink with the administration of pre-operative chemotherapy alone, the researchers want to see if the tumors will shrink even more, or possibly disappear, with the added Herceptin.
Though the researchers hope that Herceptin will be found beneficial to early-stage breast cancer patients before they have surgery, they will also closely monitor patients for potential side effects.This is because Herceptin has been associated with an increased risk of cardiovascular problems, including ventricular dysfunction and congestive heart failure. The study participants will be checked for heart problems prior to and throughout the trial.
Other, more common side effects of Herceptin include:
- Nausea (especially when given with chemotherapy)
- Increased cough
Please see the references section below for a link to more information about the Herceptin trial, including information on how to enroll.
- The October 29, 2001 M.D. Anderson news release, First Clinical Trial to Examine Herceptin as Neoadjuvant Therapy for Early Breast Cancer Opens, is available on the M.D. Anderson Cancer Center website at http://www.mdanderson.org/
- To learn more about this Herceptin clinical trial, please contact the M.D. Anderson Information Line at 1.800.792.1611.
- To learn more about Herceptin and HER2, please visit http://www.imaginis.com/breasthealth/herceptin.asp