drugset / Trial / NCT00499681

PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE

NCT00499681 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving letrozole together with lapatinib works in treating postmenopausal women with stage I, stage II, or stage III breast cancer that can be removed by surgery.

Timeline

Start
2007-07
Primary completion
2009-10
Completion
2010-12

Outcome

Outcome not reported

Stopped (Enrollment): “slow accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lapatinib Small molecule 1500 mg —
Subject Letrozole Other / unclassified 2.5 mg —

Indications