Clinical trial NCT00471276: Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
Official title: A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Metastatic Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven diagnosis of breast cancer
* Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy
* Patients with at least one measurable lesion as per RECIST

Exclusion Criteria:

* Inflammatory breast cancer
* Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)

Primary outcomes:
measure: Number of Participants With Objective Response
timeFrame: Baseline, Week 9, and every 8 weeks up to Month 34
Secondary outcomes:
measure: Number of Participants With Clinical Benefit
timeFrame: Baseline, Week 9, and every 8 weeks up to Month 34
measure: Number of Participants With Objective Response of Superficial Lesions
timeFrame: Baseline, every 4 weeks up to Month 34
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to Month 34
measure: Duration of Response (DR)
timeFrame: Baseline up to Month 34 or early termination
measure: Overall Survival (OS)
timeFrame: Baseline until death (up to Month 34)
measure: Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy
timeFrame: Baseline, Week 9, and every 8 weeks up to Month 34
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
timeFrame: Baseline, every 4 weeks up to Month 31 or early termination
measure: Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image
timeFrame: Baseline, every 4 weeks up to Month 31 or early termination
measure: Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
timeFrame: Baseline, every 4 weeks up to Month 31 or early termination
measure: Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment
timeFrame: Baseline, every 4 weeks up to Month 31 or early termination
measure: Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning
timeFrame: Baseline, every 4 weeks up to Month 31 or early termination
measure: Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms
timeFrame: Baseline, every 4 weeks up to Month 31 or early termination
measure: Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms
timeFrame: Baseline, every 4 weeks up to Month 31 or early termination
measure: Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects
timeFrame: Baseline, every 4 weeks up to Month 31 or early termination
measure: Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss
timeFrame: Baseline, every 4 weeks up to Month 31 or early termination
measure: Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy
timeFrame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination
measure: Change From Baseline in CTSQ Score: Feelings About Side Effects
timeFrame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination
measure: Change From Baseline in CTSQ Score: Satisfaction With Therapy
timeFrame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination
Other outcomes:
measure: 1-Year Survival Probability
timeFrame: Baseline up to 1 year
Locations:
city: Bakersfield
country: United States
facility: Pfizer Investigational Site
state: California
city: Burbank
country: United States
facility: Pfizer Investigational Site
state: California
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Hawthorne
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Boynton Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Zion
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Maple Grove
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Asheville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kernersville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: North Wilkesboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Gallatin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Smyrna
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Everett
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: