Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer
Primary Study Objective:
To assess the pathological complete response rate (pCR) with 4-6 cycles of neoadjuvant chemotherapy plus erlotinib in patients with triple negative breast cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Neoadjuvant Erlotinib Plus Chemotherapy for Treatment of ER Negative, PgR Negative and HER-2 Negative Primary Breast Cancer|
- Pathological complete response rate (pCR) [ Time Frame: After 18 weeks of neoadjuvant therapy ] [ Designated as safety issue: Yes ]
- Estimation of change in ki-67 (proliferation) after 2 cycles of neoadjuvant carboplatin/docetaxel based chemotherapy [ Time Frame: After 2 cycles (6 weeks) of therapy ] [ Designated as safety issue: Yes ]
- Estimation of change in ki-67 after 2 cycles of carboplatin/docetaxel based neoadjuvant chemotherapy plus erlotinib [ Time Frame: After 2 cycles (6 weeks) of therapy ] [ Designated as safety issue: Yes ]
- Assessment of toxicity of the combination of carboplatin/docetaxel chemotherapy plus erlotinib [ Time Frame: During neoadjuvant chemotherapy ] [ Designated as safety issue: Yes ]
- Assessment of tolerability of 12 months of maintenance erlotinib treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: erlotinib with neoadjuvant chemotherapy
Study drug, erlotinib, is administered along with neoadjuvant chemotherapy. Adjuvant therapy given at discretion of treating physician. Once adjuvant therapy is completed, all patients will receive erlotinib 150 mg daily for 1 year.
Drug: Erlotinib with neoadjuvant chemotherapy
150 mg orally (PO) once daily on days 3 to 14, given with cycle 1 to 6 or 3 to 6 of neoadjuvant chemotherapy
Other Name: Tarceva
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491816
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Priyanka Sharma, M.D.||University of Kansas Medical Center|