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)

Phase 3

Completed

• Conditions: advanced breast cancer; breast cancer; HER2-negative; hormone receptor positive; 10006291

• Registration Number: NL-OMON49682
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 155

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 <=2.
• Patient has adequate bone marrow and organ function. See protocol page 40 for
more details.
• Patient must have a screening ECG with QTcF interval < 450 msec and resting
heart rate >= 50 bpm.

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Imaging parameters, FACT-B.</p><br>