Efficacy and Safety of BMS-690514 in Combination With Let... | NCT01068704

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

NCT01068704

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 12, 2015Estimated

Enrollment

4Actual

Phase

Phase 2

Conditions

Breast Cancer

Interventions

BMS-690514
Lapatinib
Letrozole

Countries

United States
Argentina
Mexico
Peru

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-016622-13	EudraCT Number

Official 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

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Feb 12, 2010

First Submission Date that Met QC Criteria

Feb 12, 2010

First Posted Date

Feb 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 24, 2012

Certification/Extension First Submitted that Passed QC Review

Sep 23, 2015

Certification/Extension First Posted Date

Oct 12, 2015Estimated

Last Update Submitted Date

Sep 23, 2015

Last Update Posted Date

Oct 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS-690514 + Letrozole	Active Comparator		Drug: BMS-690514 Drug: Letrozole
Lapatinib + Letrozole	Active Comparator		Drug: Lapatinib Drug: Letrozole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-690514	Drug	Tablets, Oral, 200 mg, once daily, ~ 12 months depending on response	BMS-690514 + Letrozole

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Oncology-Abilene		Abilene	Texas	79606	United States
Texas Oncology-Beaumont

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C552150	BMS-690514
D000077341	Lapatinib
D000077289	Letrozole

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided