NCT04538742 (DB-07) is a Phase 1, PHASE2 clinical trial of Trastuzumab deruxtecan in Metastatic Breast Cancer, sponsored by AstraZeneca.

Who is sponsoring NCT04538742?

NCT04538742 is sponsored by AstraZeneca.

What drugs are being tested in NCT04538742?

Interventions in NCT04538742: Trastuzumab deruxtecan, Durvalumab, Paclitaxel, Pertuzumab, Tucatinib.

What condition does NCT04538742 study?

NCT04538742 studies Metastatic Breast Cancer.

Is NCT04538742 still recruiting?

NCT04538742 is currently active, enrolled. Last updated 8 December 2025.

Last reviewed 2025-12-08 · How we verify

NCT04538742: DB-07

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

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

Active, enrolled Phase 1, PHASE2 Last updated 8 December 2025

What this trial tests

Phase 1, PHASE2 trial testing Trastuzumab deruxtecan in Metastatic Breast Cancer in 245 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 December 2020

Primary endpoint
31 January 2025

31 January 2030

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	245
Start date	28 December 2020
Primary completion	31 January 2025
Estimated completion	31 January 2030
Sites	72 locations across France, Italy, Russia, Taiwan, United Kingdom, Germany, Poland, South Korea

Drugs / interventions tested

Trastuzumab deruxtecan — full drug profile →
Durvalumab
Paclitaxel — full drug profile →
Pertuzumab (pertuzumab) — full drug profile →
Tucatinib (tucatinib) — full drug profile →

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

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

Sponsor's own description

DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

Publications & conference data

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

Targeting HER2-positive breast cancer: advances and future directions.
Swain SM, Shastry M, Hamilton E. · · 2023 · cited 703× · PMID 36344672 · DOI 10.1038/s41573-022-00579-0
The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors.
Wei Q, Li P, Yang T, Zhu J, et al · · 2024 · cited 102× · PMID 38178200 · DOI 10.1186/s13045-023-01509-2
Mechanisms of Resistance to Antibody-Drug Conjugates.
Khoury R, Saleh K, Khalife N, Saleh M, et al · · 2023 · cited 100× · PMID 37298631 · DOI 10.3390/ijms24119674
Emerging Targeted Therapies for HER2-Positive Breast Cancer.
Mercogliano MF, Bruni S, Mauro FL, Schillaci R. · · 2023 · cited 95× · PMID 37046648 · DOI 10.3390/cancers15071987
Trastuzumab Deruxtecan in HER2-Positive Metastatic Breast Cancer Patients with Brain Metastases: A DESTINY-Breast01 Subgroup Analysis.
Jerusalem G, Park YH, Yamashita T, Hurvitz SA, et al · · 2022 · cited 90× · PMID 36255231 · DOI 10.1158/2159-8290.cd-22-0837
Trastuzumab Deruxtecan: Changing the Destiny of HER2 Expressing Solid Tumors.
Indini A, Rijavec E, Grossi F. · · 2021 · cited 81× · PMID 33946310 · DOI 10.3390/ijms22094774
Management of patients with advanced-stage HER2-positive breast cancer: current evidence and future perspectives.
Marra A, Chandarlapaty S, Modi S. · · 2024 · cited 79× · PMID 38191924 · DOI 10.1038/s41571-023-00849-9
Immunotherapy in Breast Cancer.
Dvir K, Giordano S, Leone JP. · · 2024 · cited 74× · PMID 39062758 · DOI 10.3390/ijms25147517

Verify or expand the search:

Other trials of Trastuzumab deruxtecan

Trials testing the same drug.

NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer · EARLY_PHASE1 · not yet recruiting
NCT07086768 — Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metast · Phase 1 · not yet recruiting
NCT07124000 — DESTINY-PANTUMOUR04 · recruiting
NCT07060807 — A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) · Phase 3 · recruiting
NCT06989112 — DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Tre · Phase 3 · 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

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · 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 NCT04538742 (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 AstraZeneca
Last refreshed: 8 December 2025

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/NCT04538742.

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