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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: Lapatinib
Drug: Letrozole
Drug: BMS-690514

Study type

Interventional

Funder types

Industry

Identifiers

NCT01068704
2009-016622-13 (EudraCT Number)
CA187-016

Details and patient eligibility

About

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

Enrollment

4 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4 participants in 2 patient groups

BMS-690514 + Letrozole
Active Comparator group
Treatment:
Drug: Letrozole
Drug: BMS-690514
Lapatinib + Letrozole
Active Comparator group
Treatment:
Drug: Letrozole
Drug: Lapatinib

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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