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Kisqali 200 mg film-coated tablets

DRUG19 trials

Sponsors

Pfizer Inc., Unicancer, Blueprint Medicines Corp., F. Hoffmann-La Roche AG, AstraZeneca AB

Conditions

Advanced Breast Cancer in older patientsBreast cancerER+ HER2- Breast cancerER+/HER2- Advanced or Metastatic Breast CancerER+/HER2- early breast cancerEarly Breast CancerEarly-StageEstrogen receptor (ER)-positive

Phase 1

Phase 2

SAFIR 03_A ctDNA screening program in patients with HR+, HER2- metastatic breast cancer for detection of high-risk relapse patients on any CDK4/6 inhibitor and a randomised phase II study comparing alpelisib combined with fulvestrant to ribociclib combined with fulvestrant, in patients with persistent targetable PIK3CA mutations.
CompletedCTIS2022-502372-22-01
UnicancerHER2-, Metastatic Breast Cancer HR+
Start: 2023-10-19End: 2025-11-24Target: 1080Updated: 2025-02-28
Neoadjuvant and adjuvant RIBOciclib and endocrine therapy for cLinicAlly high-RISk estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer (RIBOLARIS)
Active, not recruitingCTIS2023-508827-10-00
Solti Groupgrade 2 or 3, HR+/HER2breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole., Ki67 #20% +1
Start: 2025-10-13Target: 1100Updated: 2026-01-07
ABCSG 63 / ERIKA: Elacestrant and RIbociclib in Ki67-tested endocrine responsive breAst cancer: An open-label, two-arm, randomized, phase II study of elacestrant plus ribociclib vs. AI (plus GnRH agonist in pre-/perimenopausal women and men) plus ribociclib as neoadjuvant therapy for endocrine-responsive HER2-negative early breast cancer
RecruitingCTIS2023-505758-17-00
Verein Zur Praevention Und Therapie Boesartiger Erkrankungen Austrian Breast And Colorectal Cancer Study Groupendocrine-responsive HER2-negative early breast cancer
Start: 2025-08-21Target: 120Updated: 2025-12-10
A randomized phase II study to evaluate the safety and efficacy of trastuzumab deruxtecan versus CDK4/6 inhibitor-based endocrine therapy as first-line therapy of HR-positive and HER2-low/ultra-low advanced breast cancer patients classified as non-luminal subtype according to gene expression profiling (The PONTIAC Study).
RecruitingCTIS2024-512360-55-00
Medica Scientia Innovation Research S.L.Unresectable locally recurrent or metastatic hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-low/ultralow breast cancer classified as non-luminal by gene expression profiling.
Start: 2025-06-30Target: 194Updated: 2026-01-16
A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment with Inavolisib Combinations in Patients with Untreated, Early-Stage, PIK3CA-Mutated Breast Cancer
RecruitingCTIS2024-518811-20-00
F. Hoffmann-La Roche AGEarly-Stage, PIK3CA-Mutated Breast Cancer (BC)
Start: 2025-09-30Target: 34Updated: 2025-10-21
Prevention of Ribociclib-related hepatotoxicity in breast cancer patients: a phase II, multicentre, open label, single arm trial of Silimarin.
Not yet recruitingCTIS2025-521651-22-00
Fondazione Oncotech Impresa SocialeHER2-negative breast cancer, hormone receptor positive
Target: 170Updated: 2026-02-17

Phase 3

A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
RecruitingCTIS2023-504997-39-00
AstraZeneca ABHormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer
Start: 2021-06-14Target: 214Updated: 2026-01-26
IMPlementing geriatric assessment for dose Optimization of CDK 4/6-inhibitors in older bReasT cAncer patieNTs – a pragmatic randomized-controlled trial (IMPORTANT trial)
RecruitingCTIS2023-506620-87-00
Region Oerebro LaenAdvanced Breast Cancer in older patients
Start: 2024-01-25Target: 495Updated: 2025-07-10
A Phase III, Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared with Fulvestrant, both Combined with a CDK4/6 Inhibitor, in Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer with Resistance to Prior Adjuvant Endocrine Therapy
RecruitingCTIS2022-502980-39-00
F. Hoffmann-La Roche AGEstrogen receptor (ER)-positive, HER2-negative advanced breast cancer
Start: 2024-01-25Target: 296Updated: 2026-01-13
A Phase III, multicenter, open-label study of ribociclib vs. palbociclib in patients with advanced hormone receptor-positive/HER2-negative/HER2-Enriched breast cancer - HARMONIA
Active, not recruitingCTIS2023-508828-35-01
Solti GroupPatients with advanced hormone receptor-positive/HER2- negative/HER2-Enriched breast cancer
Start: 2022-03-28Target: 316Updated: 2025-06-20
Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing endocrine therapy plus ribociclib versus chemotherapy in intermediate-risk, HR+/HER2- early breast cancer (ADAPTcycle)
Active, not recruitingCTIS2024-515769-32-00
WSG Westdeutsche Studiengruppe GmbHHR+/HER2- early breast cancer
Start: 2019-07-02Target: 1684Updated: 2024-10-01
Selecting the optimal position of CDK4/6 inhibitors in HR+ advanced breast cancer: the SONIA trial
Active, not recruitingCTIS2024-516204-42-00
BOOG Study Center B.V.Breast cancer
Start: 2017-11-21Target: 1050Updated: 2024-11-12
Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing adjuvant Elacestrant with standard endocrine treatment in genomically and/or clinically high-risk ER+/HER2- early breast cancer (ADAPTela)
Not yet recruitingCTIS2025-522484-15-00
WSG Westdeutsche Studiengruppe GmbHER+/HER2- early breast cancer
Target: 1050Updated: 2026-03-11

Phase 4

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