Phase 2
N=217
Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00246571 ↗Enrolled (actual)
217
Serious AEs
28.6%
Results posted
Jun 2011
Primary outcome: Primary: Progression-Free Survival (PFS) — 2.0; 2.7; 1.7; 2.5 Months — p=0.8885
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SU011248 (Drug); Chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
2.0; 2.7; 1.7; 2.5 | 0.8885 |
| SECONDARY Proportion of Participants With Objective Response |
2.7; 6.7; 8.8; 11.5 | 0.9624 |
| SECONDARY Duration of Response (DR) |
3.0; NA; 3.6; 4.6 | — |
| SECONDARY Survival Probability at 1 Year |
0.376; 0.446 | — |
| SECONDARY Overall Survival (OS) |
9.4; 10.5 | 0.8394 |
| SECONDARY 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) |
— | — |
| SECONDARY HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score |
— | — |
| SECONDARY Observed Plasma Trough Concentrations (Ctrough) of Sunitinib |
0.12; 65.53; 62.09; 58.20; 50.03; 64.61 | — |
| SECONDARY Ctrough of SU012662 (Metabolite of Sunitinib) |
0.02; 29.4; 32.3; 33.4; 28.5; 40.4 | — |
| SECONDARY Ctrough of Total Drug (Sunitinib + SU012662) |
0.14; 94.9; 94.4; 91.6; 78.6; 105 | — |
| SECONDARY Dose-corrected Ctrough of Sunitinib |
NA; 67.5; 73.4; 69.8; 69.3; 65.3 | — |
| SECONDARY Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib) |
NA; 29.9; 37.2; 37.3; 39.8; 40.1 | — |
| SECONDARY Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662) |
NA; 97.4; 111; 107; 109; 105 | — |
| SECONDARY Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2) |
— | — |
| SECONDARY Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3) |
24124.82; 25857.19; 16299.70; 24515.83; 14459.38; 29034.86 | — |
| SECONDARY Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A) |
152.28; 151.49; 455.17; 170.43; 265.56; 129.31 | — |
| SECONDARY Plasma Concentration of Soluble Placental Growth Factor (sPlGF) |
36.96; 37.23; 168.05; 36.24; 72.16; 40.08 | — |
| SECONDARY Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor |
61862.65; 62232.81; 44987.88; 65843.75; 30855.10; 63582.86 | — |
| SECONDARY Circulating Endothelial Cells (CEC) |
944.67; 1176.92; 630; 1199.32; 512.39; 1048.31 | — |
| SECONDARY Circulating Tumor Cells (CTC) |
119.76; 17.71; 183.60; 10.69; 189; 3.18 | — |
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
Data sourced from ClinicalTrials.gov (NCT00246571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.