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Sponsors and Collaborators: |
Stanford University GlaxoSmithKline Sanofi-Aventis |
Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00404066 |
This trial combines dose dense chemotherapy with Doxorubicin and Cyclophosphamide (AC) followed by standard every 3 week docetaxel and GW572016 for neoadjuvant treatment of her2neu positive stage II/III breast cancer. GW572016 or Lapatinib, the investigational agent, acts as a duel inhibitor of both epidermal growth factor receptor (EGFR) and ErbB-2 (Her2/neu) tyrosine kinase activity. EGFR and ErbB2 receptors are frequently over-expressed or altered in human cancers including breast cancer. This study plans to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.
Condition | Intervention | Phase |
Breast Cancer |
Drug: Lapatinib Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Docetaxel Lapatinib Lapatinib Ditosylate Trastuzumab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Phase II Neoadjuvant Chemotherapy Trial in Clinical Stage II/III Her2Neu Positive Breast Cancer With Sequential AC"³Docetaxel With Concurrent Dual EGFR Kinase Blockade by GW572016 (Lapatinib) Followed by 1 Year Adjuvant Trastuzumab |
Estimated Enrollment: | 71 |
Study Start Date: | October 2006 |
This trial combines dose dense chemotherapy with Doxorubicin and Cyclophosphamide (AC) followed by standard every 3 week docetaxel and GW572016 for neoadjuvant treatment of her2neu positive stage II/III breast cancer. GW572016 or Lapatinib, the investigational agent, acts as a duel inhibitor of both epidermal growth factor receptor (EGFR) and ErbB-2 (Her2/neu) tyrosine kinase activity. EGFR and ErbB2 receptors are frequently over-expressed or altered in human cancers including breast cancer. This study plans to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.
The primary objective of the study is to improve pathological complete response rates with the addition of dual EGFR blockade. Neoadjuvant chemotherapy which achieves pathologic complete responses (pCR) has been shown to predict improved long-term survival and serves as a surrogate for clinical outcome. By using this primary endpoint we can obtain statistical data with smaller patient numbers and at a lower overall cost. Additionally, we hope to correlate clinical and radiologic outcomes with gene expression data.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Women with histologically confirmed Her2neu positive breast cancer. Patients are considered Her2Neu positive by either Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+
Patients must have normal organ and marrow function as defined below:
Hematologic (minimal values)
Hepatic
Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the Principal Investigator
United States, California | |||||
Stanford University School of Medicine | Recruiting | ||||
Stanford, California, United States, 94305 | |||||
Contact: Mary Chen 650-723-8686 mmjchen@stanford.edu | |||||
Contact: Cancer Clinical Trials Office (650) 498-7061 | |||||
Principal Investigator: Dr. Ellie Guardino MD/PhD | |||||
Sub-Investigator: Robert W Carlson |
Stanford University |
GlaxoSmithKline |
Sanofi-Aventis |
Principal Investigator: | Dr. Ellie Guardino MD/PhD | Stanford University |
Study ID Numbers: | BRSADJ0002, 96692, BRSADJ0002, NCT00404066 |
First Received: | November 22, 2006 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00404066 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
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