Abstract
Background: This is a randomized, multicenter, open-label, Phase II study designed to evaluate the efficacy of everolimus added to continuous aromatase inhibitor (AI) administration in patients who had maintained stable disease or a better response for at least 5 months. Patients and methods: Patients will be randomized to everolimus and standard therapy groups (1:1 ratio). In the everolimus group, patients will receive everolimus in addition to the AI agent. The standard therapy group will continue AI alone treatment. The primary endpoint is progression-free survival. Target accrual is 130 patients with a two-sided type I error rate of 10% and 80% power to detect 35% risk reduction. Conclusion: The Chloe trial will provide important information about the efficacy and safety of adding everolimus to AI in patients with estrogen receptor-positive and human epidermal growth factor 2-negative metastatic breast cancer.
| Original language | English |
|---|---|
| Pages (from-to) | 13-18 |
| Number of pages | 6 |
| Journal | Open Access Journal of Clinical Trials |
| Volume | 10 |
| DOIs | |
| Publication status | Published - Feb 16 2018 |
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Keywords
- Aromatase inhibitor
- Breast cancer
- Everolimus
- Hormone receptor-positive
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
- Pharmacology (medical)
Cite this
Open-label Phase II study of everolimus plus endocrine therapy in postmenopausal women with ER-positive and HER2-negative metastatic breast cancer (Chloe trial). / Shimoi, Tatsunori; Shimomura, Akihiko; Shien, Tadahiko; Uemura, Yukari; Kato, Hiroaki; Kitada, Masahiro; Toyama, Tatsuya; Aihara, Tomohiko; Mukai, Hirofumi.
In: Open Access Journal of Clinical Trials, Vol. 10, 16.02.2018, p. 13-18.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Open-label Phase II study of everolimus plus endocrine therapy in postmenopausal women with ER-positive and HER2-negative metastatic breast cancer (Chloe trial)
AU - Shimoi, Tatsunori
AU - Shimomura, Akihiko
AU - Shien, Tadahiko
AU - Uemura, Yukari
AU - Kato, Hiroaki
AU - Kitada, Masahiro
AU - Toyama, Tatsuya
AU - Aihara, Tomohiko
AU - Mukai, Hirofumi
PY - 2018/2/16
Y1 - 2018/2/16
N2 - Background: This is a randomized, multicenter, open-label, Phase II study designed to evaluate the efficacy of everolimus added to continuous aromatase inhibitor (AI) administration in patients who had maintained stable disease or a better response for at least 5 months. Patients and methods: Patients will be randomized to everolimus and standard therapy groups (1:1 ratio). In the everolimus group, patients will receive everolimus in addition to the AI agent. The standard therapy group will continue AI alone treatment. The primary endpoint is progression-free survival. Target accrual is 130 patients with a two-sided type I error rate of 10% and 80% power to detect 35% risk reduction. Conclusion: The Chloe trial will provide important information about the efficacy and safety of adding everolimus to AI in patients with estrogen receptor-positive and human epidermal growth factor 2-negative metastatic breast cancer.
AB - Background: This is a randomized, multicenter, open-label, Phase II study designed to evaluate the efficacy of everolimus added to continuous aromatase inhibitor (AI) administration in patients who had maintained stable disease or a better response for at least 5 months. Patients and methods: Patients will be randomized to everolimus and standard therapy groups (1:1 ratio). In the everolimus group, patients will receive everolimus in addition to the AI agent. The standard therapy group will continue AI alone treatment. The primary endpoint is progression-free survival. Target accrual is 130 patients with a two-sided type I error rate of 10% and 80% power to detect 35% risk reduction. Conclusion: The Chloe trial will provide important information about the efficacy and safety of adding everolimus to AI in patients with estrogen receptor-positive and human epidermal growth factor 2-negative metastatic breast cancer.
KW - Aromatase inhibitor
KW - Breast cancer
KW - Everolimus
KW - Hormone receptor-positive
UR - http://www.scopus.com/inward/record.url?scp=85046673541&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85046673541&partnerID=8YFLogxK
U2 - 10.2147/OAJCT.S155706
DO - 10.2147/OAJCT.S155706
M3 - Article
AN - SCOPUS:85046673541
VL - 10
SP - 13
EP - 18
JO - Open Access Journal of Clinical Trials
JF - Open Access Journal of Clinical Trials
SN - 1179-1519
ER -