Phase 2
Completed N=83
Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00471276 ↗Enrolled (actual)
83
Serious AEs
15.7%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With Objective Response — 7 Participants
Summary
Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
7 | — |
| SECONDARY Number of Participants With Clinical Benefit |
9 | — |
| SECONDARY Number of Participants With Objective Response of Superficial Lesions |
3 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.6 | — |
| SECONDARY Duration of Response (DR) |
3.4 | — |
| SECONDARY Overall Survival (OS) |
15.6 | — |
| SECONDARY Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy |
1 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score |
0.0; -8.3; -16.7; -8.3; -8.3; 66.7 | — |
| SECONDARY Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image |
0.0; 0.0; 0.0; 0.0; 0.0; 83.3 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective |
0.0; -33.3; -33.3; 0.0; -16.7; 66.7 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment |
0.0; 0.0; 0.0; 0.0; 0.0; 33.3 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning |
0.0; 0.0; 0.0; 0.0; 0.0; 100.0 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms |
0.0; 0.0; 0.0; 0.0; 0.0; 11.1 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms |
0.0; 0.0; 0.0; 0.0; 0.0; 8.3 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects |
14.3; 19.0; 14.3; 23.8; 19.0; 14.3 | — |
| SECONDARY Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy |
70.00; 20.00; 0.00; 5.00; 5.00; 17.50 | — |
| SECONDARY Change From Baseline in CTSQ Score: Feelings About Side Effects |
3.13; 0.00; 0.00; 0.00; -6.25; 62.50 | — |
| SECONDARY Change From Baseline in CTSQ Score: Satisfaction With Therapy |
8.93; 10.71; 7.14; 11.79; -1.79; 71.43 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically proven diagnosis of breast cancer
- Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy
- Patients with at least one measurable lesion as per RECIST
Exclusion Criteria
- Inflammatory breast cancer
- Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)
Data sourced from ClinicalTrials.gov (NCT00471276). 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.