Study of efficacy and safety of LEE011 ribociclib (LEE011) in combination with letrozole in patients with advanced breast cancer

Phase 1

• Conditions: HR+, HER2- advanced breast cancer; MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002556-24-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-31
• Study Completion: 2020-02-06
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

- Adult = 18 years old at the time of informed consent and has signed informed consent before any trial related activities.
- Patients with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
- For inclusion in the 70% arm: Men or postmenopausal women.
- For the 30% arm, also premenopausal or perimenopausal patients may be included
- For premenopausal patients: Confirmed negative serum pregnancy test (ß-hCG) before starting study treatment or patient has had a hysterectomy
- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
- Patient has HER2-negative breast cancer
- Measurable disease
- ECOG performance status 0 or 1 or 2
- Patient has adequate bone marrow and organ function
- Standard 12-lead ECG values assessed by the local laboratory

Complete list of inclusion criteria: See Protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 260

Exclusion Criteria

- Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator’s best judgment
- prior CDK4/6 inhibitor
- prior mTOR-inhibitor
- known hypersensitivity to any of the excipients of ribociclib , letrozole (or goserelin if pre- or perimenopausal)
- current inflammatory breast cancer (< 4 weeks before enrollment)
- concurrently using other anti-cancer therapy
- had major surgery within 14 days prior to starting study drug or has not recovered from major side effects

Complete list of exclusion criteria: See Protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified