Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer

PHASE1TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Breast Cancer
Interventions
DRUG

KW-2450 in combination with lapatinib and letrozole

Three subjects will be assigned to each of 4 sequential cohorts. Dose escalation may proceed once at least 3 subjects have completed 30 days of study treatment. Subjects who withdraw prior to completing Day 30 for reasons other than DLT will be replaced. If a DLT is observed, additional subjects may be enrolled so that up to 6 subjects are enrolled at that dose level.

Trial Locations (5)

33136

Sylvester Comprehensive Cancer Center, Deerfield Beach

48336

Clinical Oncology Associates, Farmington Hills

77030

MD Anderson Cancer Center, Houston

90057

Associates in Hematology-Oncology, Los Angeles

90250

Breastlink Research Group, Long Beach

Sponsors
All Listed Sponsors
collaborator

Kyowa Hakko Kirin Pharma, Inc.

INDUSTRY

lead

Kyowa Kirin Co., Ltd.

INDUSTRY