Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01068704

Enrollment

Registered

2010-02-15

Start date

2010-06-30

Completion date

2010-12-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy

Interventions

DRUGBMS-690514

Tablets, Oral, 200 mg, once daily, \ 12 months depending on response

DRUGLapatinib

Tablets, Oral, 1500 mg, once daily, \ 12 months depending on response

DRUGLetrozole

Tablets, Oral, 2.5 mg, once daily, \ 12 months depending on response

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented invasive breast cancer * Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor * HER2+ and HER2- (Human Epidermal growth factor Receptor) disease * Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane * ECOG Performance status = 0 or 1

Exclusion criteria

* Prior hormonal therapy for metastatic disease * Prior hormonal therapy with letrozole for adjuvant disease * Symptomatic brain metastases * Prior treatment with any tyrosine kinase inhibitor

Design outcomes

Primary

Measure	Time frame
Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months	Every 8 weeks according to CT scan

Secondary

Measure	Time frame
Progression Free Survival: defined as time to disease progression	Every 8 weeks
Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'	Every 8 weeks
Frequency and severity of adverse events in all subjects	Every 4 weeks

Countries

Argentina, Mexico, Peru, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026