Posts Tagged ‘her-2 positive’

New Treatment for Her-2+ Metastatic Breast Cancer Opens at CORT

September 4, 2009

CORT has opened the Wyeth 3144A2 3005 WW Study testing the oral her-2 inhibitor, neratinib, in combination with paclitaxel (Taxol), versus standard therapy with trastuzumab (Herceptin) in combination with paclitaxel, for first-line treatment of her-2+ metastatic breast cancer. 

Neratinib is an oral anti-her-1/her-2 drug with demonstrated efficacy in metastatic her-2 positive breast cancer.  The safety studies have demonstrated acceptable and manageable toxicity of neratinib, including rash and occasional loose stools or diarrhea being most common.  As with other her-2 inhibiting drugs, neratinib may lower the cardiac ejection fraction, so serial monitoring of cardiac function is routine.  The Phase III study will compare the efficacy and tolerability of paclitaxel with either oral neratinib or trastuzumab (a monoclonal antibody against her-2 protein, given IV).

The potential advantages of neratinib include improved convenience (and possibly improved safety).  The drug is given orally.  

For more information about this study, visit our website at, or contact a Research Coordinator at 972-566-5588.  

Patients with her-2+ breast cancer may also be eligible for other studies and treatment at CORT, including non-study therapy.  The principle investigator at CORT is Dr. Barry Mirtsching.  He has personally conducted over 200 trials in cancer therapy over 16 years, many in breast cancer management.  Experience in both trial and non-trial breast cancer management benefits patients by producing better treatment outcomes.  Care at CORT is individual and personal, with adequate time for problem-solving and direct contact with the physician.

Study Tests Extension of Anti-Her-2 Therapy Beyond Herceptin for Early Stage Breast Cancer Patients

August 5, 2009

The Wyeth Study 3144A2-3004-WW testing a new oral drug, neratinib, is active and enrolling at CORT.  This study is open to early-stage, her-2 positive patients who have completed adjuvant therapy and one year of trastuzumab (Herceptin), the current standard-of-care.  Such patients are generally followed without further treatment.  The relapse risk of these patients is reduced by the one year of trastuzumab (see Figure 1: Analysis of Relapse Risk over Time, adapted from Herceptin Product Literature).  

Annual Relapse Risk for Her-2 Positive Early-Stage Breast Cancer Patients, Treated with or without Trastuzumab

As can be seen from the figure, the AC>TH arm has a lower risk of annual recurrence that begins during the first year (the time the treatment with trastuzumab is given), and that benefit continues, when compared to patients treated with chemotherapy alone (AC>T).  However, the risk for recurrence does rise in the trastuzumab-treated patients after the therapy is completed at one year, and that risk remains increased for another 2 or 3 years, at approximately 4.9% per year. 

To address that continued risk, studies testing the extension of anti-her-2 therapy are being conducted.  The Wyeth study at CORT tests the oral anti-her-2 drug neratinib (HKI-272).  The study is a randomized comparison of neratinib versus a neratinib placebo, given daily by mouth for one year.  Neratinib may reduce cardiac function (similar to other her-2 blockers), so function must be monitored.  Other risks include rash, diarrhea, and nausea.  Based on experience with the drug to date, these risks can be managed with supportive care medication and/or dose reduction in most circumstances. 

Patients who have completed one year of adjuvant therapy with trastuzumab (Herceptin), and who are within 2 years of completion of that therapy are eligbile for the Wyeth study at CORT. 

For more information about this study, or to schedule a consultation about management of breast cancer, call 972-566-5588, and ask to speak with a Patient Care Coordinator.   Additional information about this study, and directions to the office are located at: