|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by (Responsible Party): | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01160211 |
Purpose
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms, Breast |
Drug: lapatinib Drug: trastuzumab Drug: Aromatase inhibitor |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ph III Trial to Compare Safety and Efficacy of Lapatinib Plus Trastuzumab Plus Aromatase Inhibitor (AI) vs. Trastuzumab Plus AI vs. Lapatinib Plus AI as 1st Line in Postmenopausal Subjects With Hormone Receptor+ HER2+ MBC Who Received Trastuzumab and Endocrine Therapy in Neo- and/or Adjuvant Setting |
| Estimated Enrollment: | 525 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lapatinib plus trastuzumab plus aromatase inhibitor |
Drug: lapatinib
1000 mg by mouth once a day
Drug: trastuzumab
Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks
Drug: Aromatase inhibitor
Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily
|
| Active Comparator: trastuzmab plus aromatase inhibitor |
Drug: trastuzumab
Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks
Drug: Aromatase inhibitor
Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily
|
| Active Comparator: lapatinib plus aromatase inhibitor |
Drug: Aromatase inhibitor
Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily
Drug: lapatinib
1500 mg by mouth once daily
|
This is a Phase III, randomized, open-label, multi-center, three arm study of lapatinib plus trastuzumab plus an aromatase inhibitor (AI), trastuzumab plus an AI, or lapatinib plus an AI to evaluate the efficacy and safety of these regimens as first-line therapy in postmenopausal subjects with hormone receptor positive (HR+), HER2-positive metastatic breast cancer (MBC) who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting. Eligible subjects will be postmenopausal; have tumors that are ER and/or PgR positive and HER2-positive; have newly diagnosed Stage IV metastatic breast cancer; and have not received systemic or local treatment for MBC. The primary objective is to demonstrate superiority of lapatinib/trastuzumab/AI combination versus (vs.) trastuzumab/AI combination for overall survival. The secondary objectives are to evaluate overall survival in trastuzumab/AI vs. lapatinib/AI and trastuzumab/lapatinib/AI vs. lapatinib/AI, progression free survival, overall response rate, clinical benefit rate, the safety and tolerability of all three treatment groups (lapatinib plus trastuzumab plus an AI, trastuzumab plus an AI, or lapatinib plus an AI), and quality of life status relative to baseline.
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 128 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01160211 History of Changes |
| Other Study ID Numbers: | 114299 |
| Study First Received: | July 1, 2010 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
1st line MBC hormone receptor positive lapatinib dual HER2 suppression |
trastuzumab HER2 positive aromatase inhibitor |
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Hormones Trastuzumab Lapatinib Aromatase Inhibitors |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors |