Clinical trial NCT00246571: Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
Official title: A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-30
Enrollment: 217
Sex: ALL
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 compare progression free survival for SU011248 \[sutent (sunitinib malate)\] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Recurrent or metastatic breast cancer
* Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
* Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
* Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease

Exclusion Criteria:

* More than two chemotherapy regimens for advanced disease
* Uncontrolled/symptomatic spread of cancer to the brain

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)
Secondary outcomes:
measure: Proportion of Participants With Objective Response
timeFrame: Baseline until response or disease progression (up to 3 years from first dose)
measure: Duration of Response (DR)
timeFrame: Time from first response to disease progression up to 3 years from first dose
measure: Survival Probability at 1 Year
timeFrame: Baseline until death (up to 3 years after first dose of study medication)
measure: Overall Survival (OS)
timeFrame: Baseline until death (up to 3 years after first dose of study medication)
measure: Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)
timeFrame: Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
measure: HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score
timeFrame: Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
measure: Observed Plasma Trough Concentrations (Ctrough) of Sunitinib
timeFrame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
measure: Ctrough of SU012662 (Metabolite of Sunitinib)
timeFrame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
measure: Ctrough of Total Drug (Sunitinib + SU012662)
timeFrame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
measure: Dose-corrected Ctrough of Sunitinib
timeFrame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
measure: Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)
timeFrame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
measure: Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)
timeFrame: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
measure: Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)
timeFrame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
measure: Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)
timeFrame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
measure: Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)
timeFrame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
measure: Plasma Concentration of Soluble Placental Growth Factor (sPlGF)
timeFrame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
measure: Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor
timeFrame: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
measure: Circulating Endothelial Cells (CEC)
timeFrame: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
measure: Circulating Tumor Cells (CTC)
timeFrame: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Other outcomes:
Locations:
city: Corona
country: United States
facility: Pfizer Investigational Site
state: California
city: Fullerton
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendora
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Mission Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Northridge
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Pomona
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Cucamonga
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Valencia
country: United States
facility: Pfizer Investigational Site
state: California
city: West Covina
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Tucker
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Zion
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Bloomfield Hills
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Brownstown
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Dearborn
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: West Bloomfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Biloxi
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Clarkson Valley
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Midland Park
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Morristown
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Paramus
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Pompton Plains
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Ridgewood
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Summit
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Westwood
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Clinton
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Goldsboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wilson
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Del City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Greensburg
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wexford
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richardson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Atonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tyler
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Federal Way
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Puyallup
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Pfizer Investigational Site
city: Varna
country: Bulgaria
facility: Pfizer Investigational Site
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
state: Ceska Republika
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
state: Ceska Republika
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: BESANCON Cedex 5
country: France
facility: Pfizer Investigational Site
city: BESANCON cedex
country: France
facility: Pfizer Investigational Site
city: NANTES cedex
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 20
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Aviano (PN)
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Prato, FI
country: Italy
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Gerona
country: Spain
facility: Pfizer Investigational Site
city: Lleida
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Adana
country: Turkey
facility: Pfizer Investigational Site
state: Balcali
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
state: Besevler
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
state: Pendik
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
state: Sihhiye
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
city: Oxfordshire
country: United Kingdom
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Curigliano G, Pivot X, Cortes J, Elias A, Cesari R, Khosravan R, Collier M, Huang X, Cataruozolo PE, Kern KA, Goldhirsch A. Randomized phase II study of sunitinib versus standard of care for patients with previously treated advanced triple-negative breast cancer. Breast. 2013 Oct;22(5):650-6. doi: 10.1016/j.breast.2013.07.037. Epub 2013 Aug 17.