Phase 2
Completed N=63
Study Of Sunitinib With Capecitabine In Breast Cancer
Advanced/Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00662025 ↗
Enrolled (actual)
63
Serious AEs
27.0%
Results posted
Oct 2010
Primary outcomePrimary: Number of Participants With Objective Response Based on Data Review Committee's Assessment — 19; 0; 19 participants
Summary
To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response Based on Data Review Committee's Assessment |
19; 0; 19 | — |
| SECONDARY Number of Participants With Objective Response Based on Investigator's Assessment |
17; 0; 17 | — |
| SECONDARY Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment |
32; 0; 19; 13 | — |
| SECONDARY Number of Subjects With CBR Based on Investigator's Assessment |
33; 0; 17; 16 | — |
| SECONDARY Progression-Free Survival (PFS) |
5.3 | — |
| SECONDARY Time to Tumor Progression (TTP) |
5.3 | — |
| SECONDARY Duration of Objective Tumor Response (DR) |
4.1 | — |
| SECONDARY Time to Objective Tumor Response (TTR) |
1.4 | — |
| SECONDARY Overall Survival (OS) |
20.0 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) |
68.7; 30.8; 99.5 | — |
| SECONDARY Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) |
10; 3; 6 | — |
| SECONDARY Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) |
87.7; 33.9; 119 | — |
| SECONDARY AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662) |
1886; 704; 2590 | — |
| SECONDARY Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) |
0.75; 1; 1.5; 1.5 | — |
| SECONDARY Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) |
3773; 5758; 6885; 387 | — |
| SECONDARY AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) |
5505; 13177; 12236; 635 | — |
| SECONDARY t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU) |
0.80; 1.01; 0.73; 0.77 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
- Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
- Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.
Exclusion Criteria
- Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
- Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
- Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
Data sourced from ClinicalTrials.gov (NCT00662025). 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. Informational only — not medical advice.