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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00968968 |
Purpose
This is a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible subjects will have completed 12 to 24 weeks of first- or second-line treatment with trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic lesions, or persistence of metastatic disease (stable disease) without unequivocal progression or the occurrence of new lesions, and been indicated to continue to receive trastuzumab alone as maintenance therapy. Eligible subjects entering the LPT112515 study on first-line treatment will have no known history of central nervous system (CNS) metastases; subjects entering the study on second-line treatment will have no known history of CNS metastases or have stable (asymptomatic and off steroids ≥3 months) CNS metastases. The primary objective of this study is to compare progression-free survival (PFS) in subjects with HER2-positive MBC randomized to receive treatment with lapatinib plus trastuzumab versus those randomized to receive trastuzumab alone. The secondary objectives include overall survival, clinical benefit response rate (CR, PR or SD ≥24 weeks) and the qualitative and quantitative adverse event profile of the 2 treatment arms. It is estimated that 280 subjects (140 per group) will be required to observe 193 PFS events.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma Her2+ Advanced Metastatic Breast Cancer Metastatic ErbB2 Invasive Breast Cancer Advanced Breast Cancer Cancer ErbB2+ |
Drug: Lapatinib Biological: Trastuzumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Phase III, Open-label Study of Lapatinib Plus Trastuzumab Versus Trastuzumab as Continued HER2 Suppression Therapy After Completion of First- or Second-line Trastuzumab Plus Chemotherapy in Subjects With HER2-positive Metastatic Breast Cancer |
| Estimated Enrollment: | 280 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: Lapatinib plus Trastuzumab |
Drug: Lapatinib
Oral Lapatinib 1000 mg once daily. Lapatinib is a small molecule, reversible inhibitor targeting HER2 tyrosine kinase receptor.
Biological: Trastuzumab
IV Trastuzumab 6 mg/kg every three weeks. Trastuzumab is a humanized, monoclonal antibody directed against the extracellular domain of the HER2 tyrosine kinase receptor.
|
| Active Comparator: Arm 2: Trastuzumab |
Biological: Trastuzumab
IV Trastuzumab 6 mg/kg every three weeks. Trastuzumab is a humanized, monoclonal antibody directed against the extracellular domain of the HER2 tyrosine kinase receptor.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Show 88 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00968968 History of Changes |
| Other Study ID Numbers: | 112515 |
| Study First Received: | August 27, 2009 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Adenocarcinoma Breast Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
Trastuzumab Lapatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |