Phase 1Terminated
Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KW-2450 in Combination With Lapatinib and Letrozole in Subjects With Advanced or Metastatic Breast Cancer Whose Tumors Overexpress HER2
- Sponsor
- Kyowa Kirin Co., Ltd. (Industry)
- Enrollment
- 11 enrolled
- Conditions
- Breast Cancer
- Interventions
- KW-2450 in combination with lapatinib and letrozole
- Ages
- adults, older adults
- Registry
- NCT01199367
Full record on ClinicalTrials.gov
From the registry
This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness. This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.
Primary outcomes
- To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer.
History
Last registry update
Primary completion
Started
Registered