Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Letrozole

Goserelin

Anastrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Patients in pre- and postmenopausal cohorts will be randomized in the 1:1 ratio to the experimental arm or the control arm.

Premenopausal experimental arm: NSAI + Goserelin + Ribociclib; For pre-menopausal only, patient is an adult, female ≥ 18 years old and \< 60 years old at the time of informed consent.

It is the investigators choice for NSAI based on patient's past medical history.

Postmenopausal experimental arm:

Letrozole + Ribociclib

PK Cohort: Open-label ribociclib + Letrozole treatment combination.

For postmenopausal only, patient is an adult, female ≥ 18 years old at the time of informed consent

Patients in pre- and postmenopausal cohorts will be randomized in the 1:1 ratio to the experimental arm or the control arm.

Premenopausal control arm: NSAI + Goserelin + Placebo; For pre-menopausal only, patient is an adult, female ≥ 18 years old and \< 60 years old at the time of informed consent.

It is the investigators choice for NSAI based on patient's past medical history.

Postmenopausal control arm:

Letrozole + Placebo For postmenopausal only, patient is an adult, female ≥ 18 years old at the time of informed consent

Film-coated tablets for oral use (200 mg x 3) form Day 1 of 21 of each 28 day cycle.

Ribociclib Placebo

Ribociclib

Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption).

Anastrazole: Tablets for oral use, 1mg daily (all days of every cycle without interruption) For Premenopausal cohort, it is the investigators choice for NSAI based on patients past history.

For postmenopausal and PK cohorts, all patients will be on Letrozole.

NSAI: Letrozole or Anastrazole

Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption).

Subcutaneous implant, 3.6mg on Day 1 of each 28 day cycle

Novartis Pharmaceuticals

This is a Phase II randomized, double-blind, placebo-controlled study involving premenopausal and postmenopausal Chinese women plus an open-label single arm of pharmacokinetic cohort of LEE011 in combination with Letrozole in Chinese postmenopausal women with HR+, HER2- negative advanced breast cancer.

Three cohorts of patients will be enrolled: PK cohort, premenopausal cohort, and postmenopausal cohort.

Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.

Phase II Randomized, Double-blind, Placebo-controlled Study of LEE011(Ribociclib) or Placebo in Combination With Endocrine Therapy for the Treatment of Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer, Including a Subset With Pharmacokinetic Analysis.

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.

For PK cohort only. Maximum (peak) concentration of drug in plasma.

For PK cohort only. Time to reach maximum plasma concentration.

For PK cohort only. Area under the plasma concentration curve versus time.

For pre- and postmenopausal cohorts only. Overall Survival is defined as the time from date of randomization to date of death due to any cause.

For pre- and postmenopausal cohorts only. Overall response rate is defined as the proportion of patients with best overall response (BOR) of CR or PR according to RECIST 1.1

For pre- and postmenopausal cohorts only. Clinical Benefit Rate is defined as percentage of patients with CR, PR per RECIST or SD lasting 24 weeks or longer, per RECIST 1.1

For pre- and postmenopausal cohorts only. Time to response is defined as the time from the date of randomization to the first documented response either CR or PR, which must be subsequently confirmed (although date of initial response is used, not date of confirmation) according to RECIST 1.1.

For pre- and postmenopausal cohorts only. Duration of Response applies only to patients whose best overall response is CR or PR according to RECIST1.1.

For pre- and postmenopausal cohorts only. Time to definitive deterioration in ECOG performance status is defined as the time from the date of randomization to the date when ECOG performance status has definitively deteriorated by at least 1 category compared with baseline.

Spots Global Cancer Trial Database for ribociclib placebo