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OpenTrials
Completed

NCT Number: NCT01068704

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, La Rioja, La Rioja Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-690514

Drug

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

Lapatinib

Drug

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

letrozole

Drug

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

Primary outcomes

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

    Time frame: Every 8 weeks according to CT scan

Secondary outcomes

  1. Progression Free Survival: defined as time to disease progression

    Time frame: Every 8 weeks

  2. Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'

    Time frame: Every 8 weeks

  3. Frequency and severity of adverse events in all subjects

    Time frame: Every 4 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2010
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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