Phase II Trial of Neoadjuvant Erlotinib Plus Chemotherapy for Treatment of ER Negative, PgR Negative and HER-2 Negative Primary Breast Cancer
Twenty percent of women with breast cancer have triple negative breast cancer. The standard
treatment for triple negative breast cancer is typically a combination of chemotherapy,
surgery, +/- radiation therapy. When treated with standard therapy women with triple
negative breast cancer have a worse long term outcomes as compared to women who do not have
triple negative breast cancer. Triple negative breast cancer cells usually have a surface
marker called EGFR (epidermal growth factor receptor). Women whose breast cancer cells have
the EGFR surface marker have worse long term outcomes as compared to women whose tumors do
not have the EGFR marker. Erlotinib (Tarceva) targets EGFR and is currently used for
treatment of other cancers like lung and pancreas. This study will assess a combination of
chemotherapy with erlotinib in women with triple negative breast cancer.
For breast cancer patients who receive chemotherapy first and then get surgery, long-term
survival is longer for women who do not have any microscopic cancer at the time of surgery.
The primary objective of this study is to assess whether a combination of chemotherapy and
erlotinib will result in no evidence of microscopic disease (pCR) at the time of surgery in
greater than 20% of enrolled subjects. After completing all chemotherapy, patients will also
receive maintenance erlotinib for 12 months. This is given to study the tolerability of
maintenance Erlotinib and also to evaluate if maintenance erlotinib will decrease the rate
of tumor recurrence.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological complete response rate (pCR)
After 18 weeks of neoadjuvant therapy
Priyanka Sharma, M.D.
University of Kansas
United States: Institutional Review Board
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|