drugset / Trial / NCT01160211
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
RandomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2011-05-05
- Primary completion
- 2016-03-11
- Completion
- 2022-06-06
Outcome
Met primary endpoint
paper The study met its primary end point; superior PFS was observed with LAP plus TRAS plus AI versus TRAS plus AI PMID 32822287 ↗
registry analysis (superiority test); Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) vs Trastuzumab + Aromatase Inhibitor (AI); p = 0.0063; NCT01160211 ↗
Publications
- Background Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. doi: 10.1200/JCO.2017.74.7824. Epub 2017 Dec 15.
- Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. doi: 10.1200/JCO.20.01894. Epub 2020 Aug 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lapatinib | Small molecule | 1000 mg | Oral |
| Comparator | Lapatinib | Small molecule | 1500 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Anastrozole | Other / unclassified | — | Oral |
| Background | Exemestane | Small molecule | — | Oral |
| Background | Letrozole | Other / unclassified | — | Oral |