NCT02754011 (GEP14-LEECAP) is a Phase 1 clinical trial of Combination of ribociclib + capecitabine in Breast Cancer, sponsored by UNICANCER.

Who is sponsoring NCT02754011?

NCT02754011 is sponsored by UNICANCER.

What drugs are being tested in NCT02754011?

Interventions in NCT02754011: Combination of ribociclib + capecitabine.

What condition does NCT02754011 study?

NCT02754011 studies Breast Cancer.

Is NCT02754011 still recruiting?

NCT02754011 is currently completed. Last updated 7 December 2023.

Last reviewed 2023-12-07 · How we verify

NCT02754011: GEP14-LEECAP

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

Phase I Evaluating the Combination of Ribociclib+Capecitabine in Locally Advanced/Metastatic Breast Cancer HER2 Negative

Completed Phase 1 Last updated 7 December 2023

What this trial tests

Phase 1 trial testing Combination of ribociclib + capecitabine in Breast Cancer in 18 participants. Completed in 23 December 2022.

Timeline

2 February 2017

Primary endpoint
28 February 2022

23 December 2022

Quick facts

Lead sponsor	UNICANCER
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	2 February 2017
Primary completion	28 February 2022
Estimated completion	23 December 2022
Sites	2 locations across France

Drugs / interventions tested

Combination of ribociclib + capecitabine — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

UNICANCER — full company profile →

Who can join

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

Sponsor's own description

The proposed study is a multicenter, open-label phase I trial, conducted in locally advanced or metastatic breast cancer HER2 negative patients and divided into 2 parts: * STEP 1: a dose escalation part (n= up to 30) to evaluate the safety profile and pharmacokinetics and to define the MTD and RP2D to recommend in a phase II. * STEP 2: an expansion cohort part to confirm the safety and tolerability of ribociclib and capecitabine association on a longer follow-up, and to obtain preliminary evidence of anti-tumor activity on two expanded cohorts of HR positive and HR negative patients. Up to 14 patients in each cohort, taking into account patients already included in step one at this DL, may be enrolled, for a total of 28 at the RP2D.

Publications & conference data

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

Cyclin D1, cancer progression, and opportunities in cancer treatment.
Qie S, Diehl JA. · · 2016 · cited 527× · PMID 27695879 · DOI 10.1007/s00109-016-1475-3
Breast Cancer Treatments: Updates and New Challenges.
Burguin A, Diorio C, Durocher F. · · 2021 · cited 297× · PMID 34442452 · DOI 10.3390/jpm11080808
CDK4/6 inhibitors in breast cancer therapy: Current practice and future opportunities.
Lynce F, Shajahan-Haq AN, Swain SM. · · 2018 · cited 55× · PMID 29933034 · DOI 10.1016/j.pharmthera.2018.06.008
Recent advances of cyclin-dependent kinases as potential therapeutic targets in HR+/HER2- metastatic breast cancer: a focus on ribociclib.
Edessa D, Sisay M. · · 2017 · cited 11× · PMID 29263697 · DOI 10.2147/bctt.s150540
Cell-cycle targeted cancer therapy: clinical advances, biological gaps, and the emergence of selective CDK4 inhibitors.
Safaroghli-Azar A, Mekonnen LB, Lenjisa J, Milne R, et al · · 2026 · PMID 41943159 · DOI 10.1186/s13045-026-01794-7

Verify or expand the search:

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 UNICANCER trials

Trials by the same sponsor.

NCT07340619 — Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With · Phase 2 · not yet recruiting
NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test · Phase 3 · not yet recruiting
NCT07360834 — Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndr · NA · not yet recruiting
NCT07106632 — Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests · Phase 3 · not yet recruiting
NCT07294430 — Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate. · Phase 2 · not yet 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 NCT02754011 (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 UNICANCER
Last refreshed: 7 December 2023

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/NCT02754011.

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