Clinical trial NCT00696072: Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
Official title: Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: US Oncology Research
First posted: 2008-06-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
* Has measurable or evaluable-only disease
* Is female, ≥18 yrs of age, post menopausal or surgically sterile
* HER2 negative, HR+, ER+ and/or PgR+ breast cancer
* 0-1 prior chemotherapy regimen for metastatic disease.
* Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
* Prior tamoxifen therapy is allowed
* No AI therapy for \>1 year without recurrence

Exclusion Criteria:

* Pregnant or breast feeding
* Prior hormonal therapy for metastatic or locally recurrent disease
* \>1 chemotherapy regimen for metastatic disease
* Pleural or pericardial effusion
* Serious cardiac condition

Primary outcomes:
measure: Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population
timeFrame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Secondary outcomes:
measure: Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression
timeFrame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
measure: Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population
timeFrame: Day 1 to Study Completion (approximately 6 years)
measure: Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib
timeFrame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
measure: Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population
timeFrame: At 6 months and at 12 months
measure: Median Time to Treatment Failure (TTF) - ITT Population
timeFrame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths
timeFrame: First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)
Other outcomes:
Locations:
city: Sedona
country: United States
facility: Northern Arizona Hematology & Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates D.B.A. Hematology Oncology
state: Arizona
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Hudson
country: United States
facility: Florida Cancer Institute - New Hope
state: Florida
city: Carmel
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Troy
country: United States
facility: New York Oncology Hematology, Pc
state: New York
city: Kettering
country: United States
facility: Dayton Oncology And Hematology
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, Pc
state: Oregon
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Austin
country: United States
facility: Texas Oncology-Central Austin Cancer Center
state: Texas
city: Bedord
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center At Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Sammons Cancer Center
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Ctr - East
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Garland
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: Texas Oncology
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers Of South Texas
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology Cancer Center - Sugar Land
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care And Research Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates Of Southwest Virginia, Inc.
state: Virginia
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: