HR+, HER2- advanced breast cancer MedDRA version: 21.1 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Ribocilib
Product Code: LEE011 200mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIBOCICLIB
Current Sponsor code: LEE011
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical benefit rate (CBR) after 24 weeks for ribociclib (LEE011) in combination with letrozole among postmenopausal women and men with hormone receptor positive, HER2- negative, advanced breast cancer who received no prior treatment for advanced disease. (70% group) To assess the clinical benefit rate (CBR) after 24 weeks for ribociclib (LEE011) in combination with letrozole and goserelin among pre-, and perimenopausal women who received no prior treatment for advanced disease as well as pre-, peri- and postmenopausal women and men with hormone receptor positive, HER2- negative, advanced breast cancer who received no more than 1 prior chemotherapy and 2 prior lines of endocrine therapy for advanced disease (30% group) ;Secondary Objective: Progression-free survival (PFS) Overall survival (OS) Overal Response Rate (ORR) Safety and tolerability of ribociclib in combination with letrozole (and goserelin in premenopausal patients) To evaluate patient reported outcomes for health related quality of life ;Primary end point(s): Clinical Benefit Rate (CBR) after 24 weeks of treatment as defined by RECIST 1.1 as percentage of patients with CR, PR or SD lasting 24 weeks or longer;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS based on radiologic assessment by investigator using RECIST 1.1 criteria Overall survival (OS) Overall Response Rate (ORR) after 24 weeks Frequency/severity of AEs and laboratory values Time to 10% deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 Change from baseline in the global health status/QOL scale score of the EORTC QLQ-C30 ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed