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ribociclib

Generic: RIBOCICLIB SUCCINATE·Brand: KISQALI, Kisqali

ribociclib: 53 clinical trials tracked.

ribociclib evidence translation

What we can confirm

53 tracked trials

No verified listed developer

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about ribociclib, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 15 study sponsors
Clinical Trials (53)showing 10 most recent

Managed Access Programs for LEE011, Ribociclib

Available
Expanded AccessNovartis Pharmaceuticals

SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients

NCT07647328·Phase 3·AZN
Recruiting

Primary endpoint: Efficacy of camizestrant and ribociclib by time to next treatment (TTNT)

Interventionalopen150 targetStarted 2026-06Completion 2029-0250 sites · France, Germany, Italy, Poland…AstraZeneca

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

NCT07492641·Phase 3·ONC
Recruiting

Primary endpoint: Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)

InterventionalRandomizedopen1,056 targetStarted 2026-05Completion 2037-0850 sites · Australia, Brazil, China, United StatesBeOne Medicines

Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

Recruiting

Primary endpoint: Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period

Observational240 targetStarted 2026-01Completion 2029-127 sites · RussiaNovartis Pharmaceuticals

A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

NCT07174336·Phase 3·LLY
Recruiting

Primary endpoint: (Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)

InterventionalRandomizeddouble800 targetStarted 2025-12Completion 2033-0550 sites · United StatesEli Lilly and Company

Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia

Recruiting

Primary endpoint: Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort

Observational2,766 targetStarted 2025-12Completion 2032-1242 sites · RussiaNovartis Pharmaceuticals

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

NCT07085767·Phase 3·OLMA
Recruiting

Primary endpoint: Progression-Free Survival (PFS)

InterventionalRandomizedtriple1,000 targetStarted 2025-11Completion 2032-0150 sites · Australia, United StatesOlema Pharmaceuticals, Inc.

Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer

NCT07164976·Phase 1/Phase 2
Recruiting

Primary endpoint: Phase 1b part: Dose Limiting Toxicity

Interventionalopen86 targetStarted 2025-10Completion 2030-041 site · JapanNagoya City University

Real-world Evidence Non-Interventional proSpective Study of kisqaLi (Ribociclib) Effectiveness and safEty in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia

Recruiting

Primary endpoint: Invasive Breast Cancer-Free Survival (iBCFS)

Observational177 targetStarted 2025-08Completion 2028-112 sites · Saudi ArabiaNovartis Pharmaceuticals

SELECT: A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-Positive, HER2- Negative Breast Cancer With a Combination Regimen of Ribociclib and Optimized Endocrine Therapy

NCT06953882·Phase 2
Recruiting

Primary endpoint: Discontinuation rate of ribociclib in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer

InterventionalRandomizedopen140 targetStarted 2025-07Completion 2030-091 site · United StatesYale University