NCT03248427 (CORALLEEN) is a Phase 2 clinical trial of Ribociclib in Breast Cancer, sponsored by SOLTI Breast Cancer Research Group.

Who is sponsoring NCT03248427?

NCT03248427 is sponsored by SOLTI Breast Cancer Research Group.

What drugs are being tested in NCT03248427?

Interventions in NCT03248427: Ribociclib, Letrozole 2.5mg, Doxorubicin, Cyclophosphamide, Paclitaxel.

What condition does NCT03248427 study?

NCT03248427 studies Breast Cancer.

Is NCT03248427 still recruiting?

NCT03248427 is currently completed. Last updated 17 March 2021.

Last reviewed 2021-03-17 · How we verify

NCT03248427: CORALLEEN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer.

Completed Phase 2 Last updated 17 March 2021

What this trial tests

Phase 2 trial testing Ribociclib in Breast Cancer in 106 participants. Completed in 20 July 2019.

Timeline

13 July 2017

Primary endpoint
10 June 2019

20 July 2019

Quick facts

Lead sponsor	SOLTI Breast Cancer Research Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	106
Start date	13 July 2017
Primary completion	10 June 2019
Estimated completion	20 July 2019
Sites	21 locations across Spain

Drugs / interventions tested

Ribociclib (ribociclib) — full drug profile →
Letrozole 2.5mg (letrozole-2-5mg) — full drug profile →
Doxorubicin
Cyclophosphamide (cyclophosphamide) — full drug profile →
Paclitaxel — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

SOLTI Breast Cancer Research Group

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib with letrozole offers clinical benefit at least comparable to that of standard chemotherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

CDK4 and CDK6 kinases: From basic science to cancer therapy.
Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495
CDK4/6 inhibition in breast cancer: current practice and future directions.
Pernas S, Tolaney SM, Winer EP, Goel S. · · 2018 · cited 212× · PMID 30038670 · DOI 10.1177/1758835918786451
Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial.
Prat A, Saura C, Pascual T, Hernando C, et al · · 2020 · cited 152× · PMID 31838010 · DOI 10.1016/s1470-2045(19)30786-7
Cyclin-dependent protein kinases and cell cycle regulation in biology and disease.
Pellarin I, Dall'Acqua A, Favero A, Segatto I, et al · · 2025 · cited 132× · PMID 39800748 · DOI 10.1038/s41392-024-02080-z
Targeting Cell Cycle in Breast Cancer: CDK4/6 Inhibitors.
Piezzo M, Cocco S, Caputo R, Cianniello D, et al · · 2020 · cited 128× · PMID 32899866 · DOI 10.3390/ijms21186479
Updates on the CDK4/6 Inhibitory Strategy and Combinations in Breast Cancer.
Sobhani N, D'Angelo A, Pittacolo M, Roviello G, et al · · 2019 · cited 117× · PMID 30959874 · DOI 10.3390/cells8040321
Current Therapeutic Progress of CDK4/6 Inhibitors in Breast Cancer.
Wu Y, Zhang Y, Pi H, Sheng Y. · · 2020 · cited 41× · PMID 32523378 · DOI 10.2147/cmar.s250632
Photodynamic Therapy and Hyperthermia in Combination Treatment-Neglected Forces in the Fight against Cancer.
Bienia A, Wiecheć-Cudak O, Murzyn AA, Krzykawska-Serda M. · · 2021 · cited 36× · PMID 34452108 · DOI 10.3390/pharmaceutics13081147

Verify or expand the search:

Other trials of Ribociclib

Trials testing the same drug.

NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT06905301 — Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and W · recruiting
NCT06930859 — Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Recepto · recruiting
NCT07054190 — A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer · Phase 2 · recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other SOLTI Breast Cancer Research Group trials

Trials by the same sponsor.

NCT07371585 — Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management · Phase 2 · recruiting
NCT06991946 — Patient-Centric Study to Assess the Impact of Genomic Profiling on the Treatment of Patients With Metastatic Breast Canc · recruiting
NCT06236269 — HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan · Phase 2 · recruiting
NCT05885009 — Feasibility and Impact of Liquid Biopsy Genomic Profiling on Treatment Patients With Metastatic Prostate Cancer in Spain · recruiting
NCT05569811 — NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03248427 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SOLTI Breast Cancer Research Group
Last refreshed: 17 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03248427.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing