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Sponsors and Collaborators: |
Stanford University GlaxoSmithKline Sanofi-Aventis |
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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 |
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Breast Cancer |
Drug: Lapatinib Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel |
Phase II |
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 -> Docetaxel With Concurrent Dual EGFR Kinase Blockade by GW572016 (Lapatinib) Followed by 1 Year Adjuvant Trastuzumab |
Estimated Enrollment: | 71 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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)+
Baseline measurements and evaluations of tumor must be done within 3 weeks prior to initiation of treatment.
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
Exclusion Criteria:- Evidence of disease outside the breast or chest wall, except for ipsilateral axillary , supraclavicular, or infraclavicular lymph nodes.
Contact: Mary Chen | (650) 723-8686 | mmjchen@stanford.edu |
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 |
Principal Investigator: | Dr. Ellie Guardino MD/PhD | Stanford University |
Responsible Party: | Stanford University School of Medicine ( Dr. Ellie Guardino MD/PhD, a Principal Investigator ) |
Study ID Numbers: | BRSADJ0002, 96692, BRSADJ0002, NCT00404066 |
Study First Received: | November 22, 2006 |
Last Updated: | August 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00404066 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Lapatinib Cyclophosphamide Protein Kinase Inhibitors Immunosuppressive Agents |
Doxorubicin Docetaxel Anti-Bacterial Agents Trastuzumab Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors Lapatinib Cyclophosphamide Antibiotics, Antineoplastic Protein Kinase Inhibitors Immunosuppressive Agents |
Doxorubicin Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |