Abstract
Purpose: This randomized, open-label phase II study compared the efficacy of sunitinib monotherapy with that of single-agent standard-of-care (SOC) chemotherapy in patients with previously treated advanced triple-negative breast cancer (TNBC). Methods: Patients with advanced TNBC, relapsed after anthracycline- and taxane-based chemotherapy, were randomized to receive either sunitinib (37.5mg/day) or the investigator's choice of SOC therapy. Progression-free survival was the primary endpoint. Results: Median progression-free survival was 2.0 months with sunitinib and 2.7 months with SOC chemotherapy (one-sided P=0.888). Median overall survival was not prolonged with sunitinib (9.4 months) compared with SOC chemotherapy (10.5 months; one-sided P=0.839). The objective response rate was 3% with sunitinib and 7% with SOC chemotherapy (one-sided P=0.962). 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. Trial registration: NCT00246571.
| Original language | English |
|---|---|
| Pages (from-to) | 650-656 |
| Number of pages | 7 |
| Journal | Breast |
| Volume | 22 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - Oct 2013 |
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Keywords
- Phase II
- Receptor tyrosine kinases
- Standard-of-care chemotherapy
- Sunitinib
- Triple-negative breast cancer
ASJC Scopus subject areas
- Surgery
Cite this
Randomized phase II study of sunitinib versus standard of care forpatients with previously treated advanced triple-negative breastcancer. / Curigliano, Giuseppe; Pivot, Xavier; Cortés, Javer; Elias, Anthony; Cesari, Rossano; Khosravan, Reza; Collier, Mary; Huang, Xin; Cataruozolo, Patricia E.; Kern, Kenneth A.; Goldhirsch, Aron.
In: Breast, Vol. 22, No. 5, 10.2013, p. 650-656.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Randomized phase II study of sunitinib versus standard of care forpatients with previously treated advanced triple-negative breastcancer
AU - Curigliano, Giuseppe
AU - Pivot, Xavier
AU - Cortés, Javer
AU - Elias, Anthony
AU - Cesari, Rossano
AU - Khosravan, Reza
AU - Collier, Mary
AU - Huang, Xin
AU - Cataruozolo, Patricia E.
AU - Kern, Kenneth A.
AU - Goldhirsch, Aron
PY - 2013/10
Y1 - 2013/10
N2 - Purpose: This randomized, open-label phase II study compared the efficacy of sunitinib monotherapy with that of single-agent standard-of-care (SOC) chemotherapy in patients with previously treated advanced triple-negative breast cancer (TNBC). Methods: Patients with advanced TNBC, relapsed after anthracycline- and taxane-based chemotherapy, were randomized to receive either sunitinib (37.5mg/day) or the investigator's choice of SOC therapy. Progression-free survival was the primary endpoint. Results: Median progression-free survival was 2.0 months with sunitinib and 2.7 months with SOC chemotherapy (one-sided P=0.888). Median overall survival was not prolonged with sunitinib (9.4 months) compared with SOC chemotherapy (10.5 months; one-sided P=0.839). The objective response rate was 3% with sunitinib and 7% with SOC chemotherapy (one-sided P=0.962). 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. Trial registration: NCT00246571.
AB - Purpose: This randomized, open-label phase II study compared the efficacy of sunitinib monotherapy with that of single-agent standard-of-care (SOC) chemotherapy in patients with previously treated advanced triple-negative breast cancer (TNBC). Methods: Patients with advanced TNBC, relapsed after anthracycline- and taxane-based chemotherapy, were randomized to receive either sunitinib (37.5mg/day) or the investigator's choice of SOC therapy. Progression-free survival was the primary endpoint. Results: Median progression-free survival was 2.0 months with sunitinib and 2.7 months with SOC chemotherapy (one-sided P=0.888). Median overall survival was not prolonged with sunitinib (9.4 months) compared with SOC chemotherapy (10.5 months; one-sided P=0.839). The objective response rate was 3% with sunitinib and 7% with SOC chemotherapy (one-sided P=0.962). 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. Trial registration: NCT00246571.
KW - Phase II
KW - Receptor tyrosine kinases
KW - Standard-of-care chemotherapy
KW - Sunitinib
KW - Triple-negative breast cancer
UR - http://www.scopus.com/inward/record.url?scp=84884151634&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84884151634&partnerID=8YFLogxK
U2 - 10.1016/j.breast.2013.07.037
DO - 10.1016/j.breast.2013.07.037
M3 - Article
C2 - 23958375
AN - SCOPUS:84884151634
VL - 22
SP - 650
EP - 656
JO - Breast
JF - Breast
SN - 0960-9776
IS - 5
ER -