An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor- positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease (COMPLEEMENT-1, CLEE011A2404)

An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor- positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease (COMPLEEMENT-1, CLEE011A2404) - CLEE011A2404

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49682

Enrollment

155

Registered

2019-12-11

Start date

2017-01-12

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

advanced breast cancer

Interventions

Treatment with ribociclib and letrozole (and goserelin or leuprolide for men and pre / peri postmenopausal women).

breast cancer

letrozole

ribociclib

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Patient is an adult, male or female >= 18 years old at the time of informed consent. • Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. • In the case of women, both pre/perimenopausal and postmenopausal patients are allowed. See protocol page 51 for more details. • Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer. See protocol page 51 for more details. • Patients has an ECOG performance status of = 50 bpm.

Exclusion criteria

Exclusion criteria: • Patient who received any CDK4/6 inhibitor. • Patient has a known hypersensitivity to any of the excipients of the study medication. • Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease. See protocol page 52 for details. • Patient is concurrently using any other anti-cancer therapy. • Central nervous system metastases. See protocol page 53 for exceptions. • Known history of HIV. • Clinically significant, uncontrolled heart diseases, including long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome. See protocol page 53 for details. • Concommitant treatment with medications mentioned in items 13-14 on page 53/54 (CYP3A4/5 inducers/inhibitors, corticosteroids).

Design outcomes

Primary

Measure	Time frame
Adverse events.	—

Secondary

Measure	Time frame
Imaging parameters, FACT-B.	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Taiwan (Province of China), Thailand, United Arab Emirates, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)