TEAL Study for Breast

TEAL Trial for Breast Cancer Evaluation
The purpose of this interventional study is to evaluate the Pathological Complete Response (pCR) of the breast when trastuzumab emtansine (TDM1), lapatinib and Abraxane® are combined in newly diagnosed HER2 positive breast cancer. This is a randomized, open label Phase II neoadjuvant study comparing the efficacy of neoadjuvant TDM1 plus lapatinib follow by Abraxane with trastuzumab (Herceptin®) plus lapatinib follow by paclitaxel.

Desired Outcome Measures
The primary, secondary and other outcome measures are defined as follows.
  • The primary outcome measure is to evaluate the pathological complete response rate (pCR) in the breast after treatment with TDM1 plus lapatinib followed by Abraxane in women with HER2 Neu over-expressed breast cancer patients.
  • The secondary outcome measures are to determine the clinical response rate in patients with palpable disease, determine the imaging response to neoadjuvant therapy through breast imaging (mammogram, ultrasound and MRI) using RECIST, compare overall objective response rate in both treatment groups and assess toxicity, safety and efficacy of the drug combination.
  • A third outcome measure is to determine predictive markers for sensitivity and resistance to TDM1 when combined with lapatinib followed by Abraxane.

Basic Criteria for Participants

The basic criteria for participants in this study are that you be female, 18 years old or older and have histologically confirmed invasive breast cancer.

The principal investigator is Jenny C. Chang, MD. For more information, contact Houston Methodist Cancer Center at 713.441.0629 or ccresearch@houstonmethodist.org.