Phase 1
Completed N=26
Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
Source: ClinicalTrials.gov NCT00372424 ↗Enrolled (actual)
26
Serious AEs
44.0%
Results posted
Oct 2012
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 24; 11 participants
Summary
This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
24; 11 | — |
| SECONDARY Percentage of Participants With Objective Response (OR) |
72.7 | — |
| SECONDARY Progression-free Survival (PFS) |
58.4 | — |
| SECONDARY Duration of Response (DR) |
51.3 | — |
| SECONDARY Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) |
40.17; 5.96; 37.29; 5.26; 43.21; 3.36 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Docetaxel |
1117.05; 1388.63; 1316.88; 1670.40 | — |
| SECONDARY Plasma Trough Concentrations (Ctrough) of Trastuzumab |
— | — |
Eligibility Criteria
Inclusion Criteria
- Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
- Tumors over-expressing Her-2
- Candidate for treatment with docetaxel/trastuzumab
Exclusion Criteria
- Histology of inflammatory carcinoma
- AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN
Data sourced from ClinicalTrials.gov (NCT00372424). 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.