For those who haven't taken Herceptin, here's an interesting clinical trial mentioned on the website at
www.lbbc.org (Living Beyond Breast Cancer).
Study on Lapatinib Launched for HER2/neu Positive, Early-Stage Disease
By Janine E. Guglielmino, LBBC Staff
If you completed initial treatment and did not take Herceptin, you may be eligible to participate in this study of the effectiveness of lapatinib in preventing a recurrence of your cancer
Trial Starts: 7/1/2006
Sponsored By: GlaxoSmithKline
Read more about the clinical trial on lapatinib and early-stage breast cancer.
An international clinical trial will study the effectiveness of lapatinib in preventing the return of breast cancer in women with early-stage, HER2/neu, node-positive disease.
The phase III study, called
TEACH (Tykerb Evaluation After Chemotherapy) or NCT00374322, could help researchers determine whether lapatinib works as effectively as trastuzumab (brand name: Herceptin) in women with aggressive, HER2/neu positive breast cancers.
About Lapatinib
Lapatinib (brand name: Tykerb) is a
targeted therapy, a medicine that finds and attacks breast cancer cells without harming normal cells.
Lapatinib and trastuzumab are both targeted therapies; both medicines attack HER2/neu (also called ErbB2), a specific protein present on the surface of some cancer cells. These proteins control the life and death of cancer cells, how fast they grow and how quickly they spread to nearby tissues. When too much HER2/neu is present on breast cancer cells ("overexpression"), the cancer tends to be more aggressive and more likely to recur.
However, lapatinib and trastuzumab work differently. Trastuzumab attacks HER2/neu only, whereas lapatinib attacks both HER2/neu and a related molecule called HER1 (ErbB1). In previous studies, lapatinib has been shown to be effective in women with advanced (metastatic) disease whose tumors no longer respond to trastuzumab (
http://www.lbbc.org/news-detail.asp?news_id=662§ion_tag=G) and in some women with inflammatory breast cancer (
http://www.lbbc.org/news-detail.asp?news_id=1005§ion_tag=G).
Why This Study Is Important
This is the first trial to examine whether lapatinib could be used as an adjuvant (post-surgical) treatment for women with HER2/neu positive, early-stage breast cancer who are at high risk for recurrence.
The federal Food and Drug Administration has not yet approved lapatinib for any use outside clinical trials. Trastuzumab is approved for use in advanced breast cancer and for HER2/neu positive, early-stage, node-positive breast cancer as part of an adjuvant chemotherapy regimen.
Structure of the Study
Participants will be randomly assigned to one of two groups. This trial is double-blinded, meaning neither the doctor nor the participant will know to which group the participant belongs.
Group 1 participants will take a placebo (sugar pill) once a day for one year. This is the standard treatment.
Group 2 participants will take a lapatinib pill once a day for one year. This is the study treatment.
The researchers will compare the two groups to see which group goes longer without a recurrence of breast cancer, a new (unrelated) breast cancer or death from any cause. They will also compare the two groups for differences in quality of life.
Who Can Participate in the Lapatinib Study
The researchers, led by
Paul Goss, MD, PhD, and
Massachusetts General Hospital Cancer Center, seek 3,000 participants from 450 different sites around the world. You may be eligible to participate in this study if:
- You are 18 years old or older and are female
- Your pathology tests confirm your cancer is HER2/neu positive
- Your cancer is Stage 1 through Stage3b
- Your tumor was removed during surgery
- You completed chemotherapy treatments with either an anthracycline (such as doxorubicin or epirubicin) or a taxane (such as docetaxel or paclitaxel), or with any cyclophosphamide, methotrexate and 5-fluorouracil (CMF) regimen
- You have a healthy heart and good blood, liver and kidney function
- You are willing not to become pregnant during the study period
You may not participate in this study if you previously took trastuzumab therapy or if you have been diagnosed with advanced breast cancer.
For more information, contact: 800.4.CANCER
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