Clinical trial NCT00243503: Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
Official title: A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Breast Cancer Metastatic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-24
Enrollment: 60
Sex: ALL
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: The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
* HER2 positive disease (3+ by immunohistochemistry \[IHC\] or FISH-positive)
* Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

Exclusion Criteria:

* Prior treatment with \>1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
* Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
* Prior treatment on a SU11248 clinical trial.
* Uncontrolled brain metastases.

Primary outcomes:
measure: Percentage of Participants With Overall Confirmed Objective Disease Response
timeFrame: From start of treatment through 18 months
Secondary outcomes:
measure: Duration of Response (DR)
timeFrame: From start of treatment through 18 months
measure: Percentage of Participants With Clinical Benefit
timeFrame: From start of treatment through 18 months
measure: Progression Free Survival (PFS)
timeFrame: From start of treatment through 18 months
measure: Time to Progression (TTP)
timeFrame: From start of treatment through 18 months
measure: Overall Survival (OS)
timeFrame: From start of study treatment until death or 2 years from first study treatment
measure: Probability of Survival at One Year
timeFrame: From start of study treatment until death or 2 years from first study treatment
measure: EORTC QLQ-C30
timeFrame: From start of treatment through 18 months
measure: EORTC QLQ (BR23)
timeFrame: From start of treatment through 18 months
measure: Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib
timeFrame: Predose on Day 1 of Cycle 3 and 5
measure: Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
timeFrame: Predose on Day 1 of Cycle 3 and 5
measure: Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)
timeFrame: Predose on Day 1 of Cycle 3 and 5
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Harvey
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Tinley Park
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Munster
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Iberia
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Corinth
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Southaven
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Ottignies
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Besancon
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Saint Cloud
country: France
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.