Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00246571
NCT00246571CompletedPhase 2

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

Pfizer1 site in 1 country217 target enrollmentStarted: January 2006Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Pfizer
Enrollment
217
Locations
1
Primary Endpoint
Progression-Free Survival (PFS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A

Experimental

Intervention: SU011248 (Drug)

B

Active Comparator

Intervention: Chemotherapy (Drug)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Time Frame: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)

Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

Secondary Outcomes

  • Proportion of Participants With Objective Response(Baseline until response or disease progression (up to 3 years from first dose))
  • Duration of Response (DR)(Time from first response to disease progression up to 3 years from first dose)
  • Survival Probability at 1 Year(Baseline until death (up to 3 years after first dose of study medication))
  • Overall Survival (OS)(Baseline until death (up to 3 years after first dose of study medication))
  • 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)(Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal)
  • HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score(Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal)
  • Observed Plasma Trough Concentrations (Ctrough) of Sunitinib(Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3)
  • Ctrough of SU012662 (Metabolite of Sunitinib)(Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3)
  • Ctrough of Total Drug (Sunitinib + SU012662)(Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3)
  • Dose-corrected Ctrough of Sunitinib(Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3)
  • Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)(Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3)
  • Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)(Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3)
  • Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)(Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal)
  • Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)(Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal)
  • Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)(Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal)
  • Plasma Concentration of Soluble Placental Growth Factor (sPlGF)(Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal)
  • Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor(Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal)
  • Circulating Endothelial Cells (CEC)(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)
  • Circulating Tumor Cells (CTC)(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)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Terminated
Phase 1
A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast CancerBreast Neoplasms
NCT00417885Pfizer6
Completed
Phase 2
Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian CancerOvarian Clear Cell AdenocarcinomaRecurrent Ovarian Carcinoma
NCT00979992National Cancer Institute (NCI)35
Completed
Phase 1
Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate CancerProstatic Neoplasms
NCT00137436Pfizer93
Active, not recruiting
Not Applicable
A RANDOMIZED PHASE 2 STUDY OF SU011248 VERSUS STANDARD-OF-CARE FOR PATIENTS WITH PREVIOUSLY TREATED, ADVANCED, TRIPLE RECEPTOR NEGATIVE (ER, PR, AND HER2) BREAST CANCERHistologically or cytologically proven diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1).MedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancer
EUCTR2005-003774-15-HUPfizer Inc. - 235 East 42nd Street - New York - 10017200
Active, not recruiting
Not Applicable
A RANDOMIZED PHASE 2 STUDY OF SU011248 VERSUS STANDARD-OF-CARE FOR PATIENTS WITH PREVIOUSLY TREATED, ADVANCED, TRIPLE RECEPTOR NEGATIVE (ER, PR, AND HER2) BREAST CANCERocally Recurrent or Metastatic Breast CancerMedDRA version: 14.1Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2005-003774-15-ITPFIZER200