Entry Detail
| General information | |
| Database: | DB01067 |
| Objective: | sunitinib versus standard of care for patients with previously treated advanced triplenegative breast cancer. |
| Authors: | Giuseppe Curigliano |
| Title: | Randomizedphase II study of sunitinib versus standard of care for patients with previously treated advanced triplenegative breast cancer. |
| Journal: | The Breast |
| Year: | 2013 |
| PMID: | 23958375 |
| Trial Design | |
| Clinical Trial Id: | NCT00246571 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | This randomized, openlabelphase II study compared the efficacy of sunitinib monotherapy with that of singleagent standardofcare (SOC) chemotherapy in patients with previously treated advanced triplenegative breast cancer (TNBC). |
| Key Patients Feature: | aged more than and equal to 18 years with histologically or cytologically proven, unresectable, locally recurrent or MBC (advancedBC;ABC) documentedby investigators to be triplenegative. Eligible patients were to have had prior anthracycline and taxane treatment in the neoadjuvant, adjuvant, or advanceddisease setting. Disease progression must have been documented during or within 6 months of prior neoadjuvant/adjuvant chemotherapy or during or after discontinuing prior chemotherapy in the advanceddisease setting. No more than two prior chemotherapy regimens were allowed in the advanceddisease setting. Prior sunitinib treatment was not allowed. Patients were required to have an Eastern Cooperative Oncology Group performance status of 0e2 with adequate organ function and resolution of all acute toxic effects of prior therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 (NCI CTCAE v3.0) grade more than and equal to 1 (except alopecia). Uncontrolled brain metastases, cardiovascular disease within 6 months of study start, or uncontrolled hypertensionwere also criteria for exclusion. |
| Biomarker: | triple negative(human epidermal growth factor receptor 2, ER, PR) |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | sunitinib (37.5 mg/day) or the investigator¡¯s choice of SOC therapy. |
| Primary End Point: | PFS (based on independent, blinded central review), defined as time from randomization to first documented tumor progression or death on study due to any cause, whichever occurred first. |
| Secondary End Point: | safety, PFS based on investigatorassessment, objective response rate (ORR), overall survival (OS), and selected pharmacokinetic parameters. |
| Patients Number: | 217 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | The objective response rate was 3% with sunitinib and 7% with SOC chemotherapy (onesided P = 0.962) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median progression free survival was 2.0 months with sunitinib and 2.7 months with SOC chemotherapy (onesided P = 0.888). |
| Median OS A vs. C: | Median overall survival was not prolonged with sunitinib (9.4 months) compared with SOC chemotherapy (10.5 months; onesided P = 0.839). |
| Adverse Event(agent arm): | AEs of grade 3/4 were also more frequent in the sunitinib arm (55% versus 46%); the most frequent were neutropenia (21%), thrombocytopenia (11%), and asthenia and leukopenia (10% each). In the SOC arm, the most frequent grade 3/4 events were neutropenia (11%), fatigue (5%), and handefoot syndrome (5%). Hypertension (mostly lowgrade) was reported more frequently in the sunitinib arm (24% versus 4%). |
| Conclusions: | Sunitinib monotherapy did not improve efficacy compared with SOC chemotherapy in patients with previously treated advanced TNBC, for which identification of effective treatments and therapeutic targets remains an urgent need. |