NCT04263298 is a Phase 3 clinical trial of Fulvestrant in Metastatic Breast Cancer, sponsored by Herui Yao.

Who is sponsoring NCT04263298?

NCT04263298 is sponsored by Herui Yao.

What drugs are being tested in NCT04263298?

Interventions in NCT04263298: Fulvestrant, Capecitabine Oral Product.

What condition does NCT04263298 study?

NCT04263298 studies Metastatic Breast Cancer.

Is NCT04263298 still recruiting?

NCT04263298 is currently recruiting now. Last updated 30 September 2022.

Last reviewed 2022-09-30 · How we verify

NCT04263298

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

Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer

Recruiting now Phase 3 Last updated 30 September 2022

What this trial tests

Phase 3 trial testing Fulvestrant in Metastatic Breast Cancer in 210 participants. Currently enrolling.

Timeline

1 May 2018

Primary endpoint
1 May 2025

1 May 2030

Quick facts

Lead sponsor	Herui Yao
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	210
Start date	1 May 2018
Primary completion	1 May 2025
Estimated completion	1 May 2030
Sites	13 locations across China

Drugs / interventions tested

Fulvestrant (fulvestrant) — full drug profile →
Capecitabine Oral Product — full drug profile →

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Herui Yao

Who can join

Adults 18 to 75, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer.

Publications & conference data

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

Molecular Insights on Signaling Cascades in Breast Cancer: A Comprehensive Review.
Panda VK, Mishra B, Mahapatra S, Swain B, et al · · 2025 · cited 17× · PMID 39858015 · DOI 10.3390/cancers17020234
Her2-Positive Cancers and Antibody-Based Treatment: State of the Art and Future Developments.
Morales S, Gasol A, Sanchez DR. · · 2021 · cited 11× · PMID 34830927 · DOI 10.3390/cancers13225771
Clinical Evidence of Chemotherapy or Endocrine Therapy Maintenance in Patients with Metastatic Breast Cancer: Meta-Analysis of Randomized Clinical Trials and Propensity Score Matching of Multicenter Cohort Study.
Ren W, Yu Y, Hong H, Wang Y, et al · · 2022 · cited 1× · PMID 35130417 · DOI 10.4143/crt.2021.698
Fulvestrant versus capecitabine as maintenance therapy in hormone receptor-positive, HER2-negative metastatic breast cancer after first-line chemotherapy (FAMILY): a multicenter, open-label, randomized, phase 3 trial.
Wu W, Yang Y, Chen H, Lu Y, et al · · 2026 · PMID 42168151 · DOI 10.1038/s41392-026-02720-6

Verify or expand the search:

Other trials of Fulvestrant

Trials testing the same drug.

NCT07570966 — Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and · Phase 1, PHASE2 · 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
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07368998 — To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer · Phase 2 · recruiting
NCT07287917 — Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other recruiting trials for Metastatic Breast Cancer

Currently open trials in the same condition.

NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · 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 NCT04263298 (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 Herui Yao
Last refreshed: 30 September 2022

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/NCT04263298.

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