NCT05133674 is a Phase 2 clinical trial of Tamoxifen 20 mg in Breast Cancer, sponsored by Karolinska University Hospital.

Who is sponsoring NCT05133674?

NCT05133674 is sponsored by Karolinska University Hospital.

What drugs are being tested in NCT05133674?

Interventions in NCT05133674: Tamoxifen 20 mg.

What condition does NCT05133674 study?

NCT05133674 studies Breast Cancer, Breast Carcinoma, Breast Tumors, Cancer of Breast, Malignant Neoplasm of Breast.

Is NCT05133674 still recruiting?

NCT05133674 is currently status unknown. Last updated 25 May 2022.

Last reviewed 2022-05-25 · How we verify

NCT05133674

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

Therapeutic Dose Monitoring (TDM) of Tamoxifen

Status unknown Phase 2 Last updated 25 May 2022

What this trial tests

Phase 2 trial testing Tamoxifen 20 mg in Breast Cancer in 40 participants. Status unknown.

Timeline

4 April 2022

Primary endpoint
31 December 2022

1 March 2023

Quick facts

Lead sponsor	Karolinska University Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	4 April 2022
Primary completion	31 December 2022
Estimated completion	1 March 2023
Sites	1 location across Sweden

Drugs / interventions tested

Tamoxifen 20 mg — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Breast Carcinoma — all drugs for Breast Carcinoma →
Breast Tumors — all drugs for Breast Tumors →
Cancer of Breast — all drugs for Cancer of Breast →

Sponsor

Karolinska University Hospital

Who can join

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

Sponsor's own description

Tamoxifen is a potent and effective drug reducing the risk of dying from breast cancer in the adjuvant setting. Although more modern drugs have partly replaced tamoxifen, it is helpful in the neoadjuvant and metastatic settings as a single drug. Despite that, in the adjuvant setting, it is a valuable drug. This study aims to validate and study the feasibility of serial assessments, including therapeutic drug monitoring of tamoxifen, 4-hydroxytamoxifen and Z-endoxifen by capillary blood sampling, combined with patient-reported symptom scores. This will provide preliminary data to allow us to develop a future multicentre randomised clinical trial of personalised dose monitoring and adjustment of adjuvant tamoxifen therapy to enhance the quality of life and breast cancer outcomes.

Publications & conference data

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

Preliminary results using a kit to measure tamoxifen and metabolites concentrations in capillary blood samples from women with breast cancer.
Rehnmark S, Shabo I, Randahl H, Wengström Y, et al · · 2022 · cited 2× · PMID 35102224 · DOI 10.1038/s41598-022-05443-0

Verify or expand the search:

Other trials of Tamoxifen 20 mg

Trials testing the same drug.

NCT06914674 — Tamoxifen for Advanced Solid Pseudopapillary Tumor of the Pancreas · Phase 2 · recruiting
NCT04666961 — Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ · 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 Karolinska University Hospital trials

Trials by the same sponsor.

NCT07424690 — Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation · NA · not yet recruiting
NCT06639191 — [177Lu]Lu-AKIR001 First-in-human Study · EARLY_PHASE1 · recruiting
NCT03629977 — Timing of Renal Replacement Therapy in the Critically Ill Patients · recruiting
NCT06983197 — Iatrogenic Deficiencies in ICU Patients With Prolonged Continuous Renal Replacement Therapy · not yet recruiting
NCT06835816 — Amino Acid Supplementation in Continuous Renal Replacement Therapy · NA · 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 NCT05133674 (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 Karolinska University Hospital
Last refreshed: 25 May 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/NCT05133674.

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