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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months

Outcome Time Frame:

Every 8 weeks according to CT scan

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Brazil: Ministry of Health

Study ID:

CA187-016

NCT ID:

NCT01068704

Start Date:

June 2010

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Texas Oncology-AbileneAbilene, Texas  79606
Texas Oncology-BeaumontBeaumont, Texas  77702
Us Oncology Central PharmacyFort Worth, Texas  76177