NCT06048718 (TUXEDO-4) is a Phase 2 clinical trial of Trastuzumab-Deruxtecan (T-DXd) in Breast Cancer, sponsored by MedSIR.

Who is sponsoring NCT06048718?

NCT06048718 is sponsored by MedSIR.

What drugs are being tested in NCT06048718?

Interventions in NCT06048718: Trastuzumab-Deruxtecan (T-DXd).

What condition does NCT06048718 study?

NCT06048718 studies Breast Cancer, Metastatic Breast Cancer.

Is NCT06048718 still recruiting?

NCT06048718 is currently active, enrolled. Last updated 4 May 2026.

Last reviewed 2026-05-04 · How we verify

NCT06048718: TUXEDO-4

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

Phase II Study of Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-Low Breast Cancer Patients Presenting With Newly Diagnosed or Progressing Brain Metastases

Active, enrolled Phase 2 Last updated 4 May 2026

What this trial tests

Phase 2 trial testing Trastuzumab-Deruxtecan (T-DXd) in Breast Cancer in 28 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 June 2024

Primary endpoint
1 November 2026

1 November 2026

Quick facts

Lead sponsor	MedSIR
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	5 June 2024
Primary completion	1 November 2026
Estimated completion	1 November 2026
Sites	13 locations across Austria, Spain

Drugs / interventions tested

Trastuzumab-Deruxtecan (T-DXd)

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

MedSIR — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

ORR at any time point as judged by best central nervous system (CNS) response in all patients.
Time frame: From baseline until approximately 11 months after the last patient included in the study starts treatment.
To assess efficacy, defined as overall response rate (ORR) at any timepoint as judged by best CNS response according to RANO-BM criteria.

Sponsor's own description

TUXEDO-4 is an international, multicentric, single arm, phase II study aiming to gather additional solid evidence of Trastuzumab-Deruxtecan (T-DXd) activity in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-low breast cancer with active brain metastases. This study will analyze the efficacy of T-DXd as determined by overall response rate (ORR) at any timepoint as judged by best CNS response according to RANO-BM criteria.

Publications & conference data

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

Mechanisms of action and resistance to anti-HER2 antibody-drug conjugates in breast cancer.
Saleh K, Khoury R, Khalife N, Chahine C, et al · · 2024 · cited 27× · PMID 39050884 · DOI 10.20517/cdr.2024.06
Advancements in antibody-drug conjugates as cancer therapeutics.
Fong JY, Phuna Z, Chong DY, Heryanto CM, et al · · 2025 · cited 11× · PMID 40814440 · DOI 10.1016/j.jncc.2025.01.007
Analysis of HER2 expression changes from breast primary to brain metastases and the impact of HER2-low expression on overall survival.
Pereslete AM, Hughes ME, Martin AR, Files J, et al · · 2025 · cited 9× · PMID 39211994 · DOI 10.1093/neuonc/noae163
Navigating antibody‒drug conjugates (ADCs): from metastatic to early breast cancer treatment strategies.
Najdi T, Awad L, Chartouni A, Soueidy C, et al · · 2025 · cited 5× · PMID 40304863 · DOI 10.1007/s10637-025-01525-8
TUXEDO-4: phase II study of trastuzumab-deruxtecan in HER2-low breast cancer with new or progressing brain metastases.
Marhold M, Vaz Batista M, Blancas I, Morales C, et al · · 2025 · cited 5× · PMID 40018758 · DOI 10.1080/14796694.2025.2470604
Survival outcomes among patients with breast cancer and leptomeningeal disease.
Id Said B, Jerzak KJ, Chen H, Moravan V, et al · · 2025 · cited 4× · PMID 40624089 · DOI 10.1038/s41598-025-07191-3
Exploring the Role of ADCs in Brain Metastases and Primary Brain Tumors: Insight and Future Directions.
Bruzzone F, Barigazzi C, Di Muzio A, Tallarico I, et al · · 2025 · cited 3× · PMID 40361515 · DOI 10.3390/cancers17091591
Long-term response to sequential anti-HER2 therapies including trastuzumab-deruxtecan in a patient with HER2-positive metastatic breast cancer with leptomeningeal metastases: a case report and review of the literature.
de Bernardi A, Bachelot T, Larrouquère L. · · 2023 · cited 3× · PMID 38269026 · DOI 10.3389/fonc.2023.1210873

Verify or expand the search:

Other trials of Trastuzumab-Deruxtecan (T-DXd)

Trials testing the same drug.

NCT07407465 — Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal · 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 MedSIR trials

Trials by the same sponsor.

NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer · Phase 1, PHASE2 · not yet recruiting
NCT07178938 — Platform Trial Assessing Uptake, Safety and Efficacy of Theranostic Agents in Solid Tumors With Active Brain Metastases · Phase 2 · not yet recruiting
NCT05708235 — A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population · Phase 2 · recruiting
NCT05659563 — Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% · Phase 2 · completed
NCT05520723 — Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED · Phase 2 · completed

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 NCT06048718 (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 MedSIR
Last refreshed: 4 May 2026

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/NCT06048718.

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