NCT03561740 (SMART) is a Phase 3 clinical trial of capecitabine in Breast Cancer, sponsored by Sun Yat-sen University.

Who is sponsoring NCT03561740?

NCT03561740 is sponsored by Sun Yat-sen University.

What drugs are being tested in NCT03561740?

Interventions in NCT03561740: capecitabine.

What condition does NCT03561740 study?

NCT03561740 studies Breast Cancer.

Is NCT03561740 still recruiting?

NCT03561740 is currently recruiting now. Last updated 26 July 2018.

Last reviewed 2018-07-26 · How we verify

NCT03561740: SMART

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

A Study of the Addition of Metronomic Capecitabine to Standard Adjuvant Therapy in High Risk HER2+ BC paTients

Recruiting now Phase 3 Last updated 26 July 2018

What this trial tests

Phase 3 trial testing capecitabine in Breast Cancer in 794 participants. Currently enrolling.

Timeline

25 July 2018

Primary endpoint
15 June 2023

31 December 2028

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	794
Start date	25 July 2018
Primary completion	15 June 2023
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

capecitabine (capecitabine) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Breast cancer is the most common malignant tumor in women. Recurrent or metastatic breast cancer is incurable. High risk patients usually have the following characteristics, such as, non-pCR after neoadjuvant therapy, lymph nodes positive, \>2cm tumor size, HER2 overexpression, etc. Intensive targeted or chemo therapy could improve prognosis. Previous studies have shown the efficacy and feasibility of intensive treatment of capecitabine in non-pCR breast cancer patients. Given the metronomic capecitabine therapy is well tolerated, we designed this study to compare the efficacy and safety of adding metronomic capecitabine to standard adjuvant therapy for high risk HER2+ breast cancer patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Metronomic Chemotherapy in Elderly Patients.
Bandini A, Calabrò PF, Banchi M, Orlandi P, et al · · 2024 · cited 5× · PMID 38448722 · DOI 10.1007/s11912-024-01505-w

Verify or expand the search:

Other trials of capecitabine

Trials testing the same drug.

NCT07303283 — Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma · Phase 2 · not yet recruiting
NCT07177794 — Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC · Phase 3 · not yet recruiting
NCT06685289 — Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recur · Phase 2 · recruiting
NCT06802666 — Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer · Phase 2 · recruiting
NCT06607276 — Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE · 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 Sun Yat-sen University trials

Trials by the same sponsor.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · 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 NCT03561740 (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 Sun Yat-sen University
Last refreshed: 26 July 2018

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/NCT03561740.

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