NCT04571437 (B-001) is a Phase 2 clinical trial of Capecitabine in Breast Cancer, sponsored by Cairo University.

Who is sponsoring NCT04571437?

NCT04571437 is sponsored by Cairo University.

What drugs are being tested in NCT04571437?

Interventions in NCT04571437: Capecitabine, Letrozole 2.5mg.

What condition does NCT04571437 study?

NCT04571437 studies Breast Cancer, Estrogen Receptor-positive Breast Cancer, Metastatic Breast Cancer.

Is NCT04571437 still recruiting?

NCT04571437 is currently status unknown. Last updated 1 October 2020.

Last reviewed 2020-10-01 · How we verify

NCT04571437: B-001

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

Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)

Status unknown Phase 2 Last updated 1 October 2020

What this trial tests

Phase 2 trial testing Capecitabine in Breast Cancer in 204 participants. Status unknown.

Timeline

1 March 2020

Primary endpoint
31 October 2021

30 April 2022

Quick facts

Lead sponsor	Cairo University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	204
Start date	1 March 2020
Primary completion	31 October 2021
Estimated completion	30 April 2022
Sites	1 location across Egypt

Drugs / interventions tested

Capecitabine (capecitabine) — full drug profile →
Letrozole 2.5mg (letrozole-2-5mg) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Estrogen Receptor-positive Breast Cancer — all drugs for Estrogen Receptor-positive Breast Cancer →
Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Cairo University

Who can join

Adults 18 to 70, female only, with Breast Cancer or Estrogen Receptor-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.

Publications & conference data

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

Current Research Status of Metronomic Chemotherapy in Combination Treatment of Breast Cancer.
Liu J, He M, Wang Z, Li Q, et al · · 2022 · cited 17× · PMID 35988534 · DOI 10.1159/000526481
Combination of metronomic capecitabine and letrozole in metastatic hormone receptor positive, HER2 negative breast cancer: a randomized phase II trial.
Azim HA, Saleh MA, Essam Eldin P, Abdelhafeez AAM, et al · · 2025 · cited 2× · PMID 38764430 · DOI 10.1080/1120009x.2024.2342741

Verify or expand the search:

Other trials of Capecitabine

Trials testing the same drug.

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NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test · Phase 3 · not yet recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

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Other Cairo University trials

Trials by the same sponsor.

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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 NCT04571437 (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 Cairo University
Last refreshed: 1 October 2020

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/NCT04571437.

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