Randomized Phase II Study on the Additive Effect of Everolimus in Post-Menopausal Patients with Endocrine Therapy-Sensitive ER-Positive HER2-Negative Metastatic Breast Cancer

Randomized Phase II Study on the Additive Effect of Everolimus in Post-Menopausal Patients with Endocrine Therapy-Sensitive ER-Positive HER2-Negative Metastatic Breast Cancer - Chloe trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025156

Enrollment

130

Registered

2017-03-01

Start date

2017-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast cancer

Interventions

continued administration of an aromatase inhibitor + everolimus continued administration of an aromatase inhibito

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Postmenopausal patients with ER-positive HER2-negative metastatic breast cancer who maintained SD or better response for 5 months following treatment with aromatase inhibitors as a primary endocrine therapy

Exclusion criteria

Exclusion criteria: Patients who have active double cancer Patients who have a history of serious drug hypersensitivity. Patients who have serious concomitant diseases. Patients who have an active infectious disease requiring systemic treatment.

Design outcomes

Primary

Measure	Time frame
progression-free survival, PFS	—

Secondary

Measure	Time frame
overall survival(OS), response rate (RR), disease control rate (DCR), safety , time to treatment failure (TTF) , the proportion of patients who continued administration of AI agents for 1 year after the randomized allocation	—

Countries

Japan

Contacts

Public ContactMasami Shimazaki

CSPOR-BC Secretariat

office-bc@cspor-bc.or.jp03-5294-7288

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026