NCT01068704

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

February 12, 2010

Last Update Submit

September 23, 2015

Conditions

Breast Cancer

Outcome Measures

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

    Every 8 weeks according to CT scan

Secondary Outcomes (3)

  • 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

Study Arms (2)

BMS-690514 + Letrozole

ACTIVE COMPARATOR
Drug: BMS-690514Drug: Letrozole

Lapatinib + Letrozole

ACTIVE COMPARATOR
Drug: LapatinibDrug: Letrozole

Interventions

BMS-690514DRUG

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

BMS-690514 + Letrozole
LapatinibDRUG

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

Lapatinib + Letrozole
LetrozoleDRUG

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

BMS-690514 + LetrozoleLapatinib + Letrozole

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Texas Oncology-Abilene

Abilene, Texas, 79606, United States

Location

Texas Oncology-Beaumont

Beaumont, Texas, 77702, United States

Location

Us Oncology Central Pharmacy

Fort Worth, Texas, 76177, United States

Location

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, 98902, United States

Location

Local Institution

La Rioja, La Rioja Province, 5300, Argentina

Location

Local Institution

Rosario, Santa Fe Province, S2000DSK, Argentina

Location

Local Institution

Colima, Colima, 28030, Mexico

Location

Local Institution

Lima, Lima Province, 34, Peru

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BMS-690514LapatinibLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 15, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 12, 2015

Record last verified: 2015-09

Locations

AR(2)ME(1)PE(1)US(4)