NCT04132960 (DAISY) is a Phase 2 clinical trial of DS-8201a in Breast Tumors, sponsored by UNICANCER.

Who is sponsoring NCT04132960?

NCT04132960 is sponsored by UNICANCER.

What drugs are being tested in NCT04132960?

Interventions in NCT04132960: DS-8201a.

What condition does NCT04132960 study?

NCT04132960 studies Breast Tumors.

Is NCT04132960 still recruiting?

NCT04132960 is currently completed. Last updated 12 June 2025.

Last reviewed 2025-06-12 · How we verify

NCT04132960: DAISY

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

Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis

Completed Phase 2 Last updated 12 June 2025

What this trial tests

Phase 2 trial testing DS-8201a in Breast Tumors in 186 participants. Completed in 26 December 2024.

Timeline

21 October 2019

Primary endpoint
29 October 2021

26 December 2024

Quick facts

Lead sponsor	UNICANCER
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	186
Start date	21 October 2019
Primary completion	29 October 2021
Estimated completion	26 December 2024
Sites	15 locations across France

Drugs / interventions tested

DS-8201a — full drug profile →

Conditions studied

Breast Tumors — all drugs for Breast Tumors →

Sponsor

UNICANCER — full company profile →

Who can join

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

Sponsor's own description

Multicenter, open-label phase II trial assessing the efficacy of DS-8201a monotherapy in patients with metastatic breast cancer.

Publications & conference data

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

Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer.
Modi S, Jacot W, Yamashita T, Sohn J, et al · · 2022 · cited 1928× · PMID 35665782 · DOI 10.1056/nejmoa2203690
Trastuzumab deruxtecan in metastatic breast cancer with variable HER2 expression: the phase 2 DAISY trial.
Mosele F, Deluche E, Lusque A, Le Bescond L, et al · · 2023 · cited 294× · PMID 37488289 · DOI 10.1038/s41591-023-02478-2
Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions.
Ferraro E, Drago JZ, Modi S. · · 2021 · cited 164× · PMID 34380530 · DOI 10.1186/s13058-021-01459-y
Endocrine resistance in breast cancer: from molecular mechanisms to therapeutic strategies.
Saatci O, Huynh-Dam KT, Sahin O. · · 2021 · cited 110× · PMID 34623477 · DOI 10.1007/s00109-021-02136-5
HER2-directed antibodies, affibodies and nanobodies as drug-delivery vehicles in breast cancer with a specific focus on radioimmunotherapy and radioimmunoimaging.
Altunay B, Morgenroth A, Beheshti M, Vogg A, et al · · 2021 · cited 74× · PMID 33179151 · DOI 10.1007/s00259-020-05094-1
Standardized pathology report for HER2 testing in compliance with 2023 ASCO/CAP updates and 2023 ESMO consensus statements on HER2-low breast cancer.
Ivanova M, Porta FM, D'Ercole M, Pescia C, et al · · 2024 · cited 66× · PMID 37770765 · DOI 10.1007/s00428-023-03656-w
Retrospective study to estimate the prevalence and describe the clinicopathological characteristics, treatments received, and outcomes of HER2-low breast cancer.
Viale G, Basik M, Niikura N, Tokunaga E, et al · · 2023 · cited 65× · PMID 37562195 · DOI 10.1016/j.esmoop.2023.101615
Resistance to Antibody-Drug Conjugates Targeting HER2 in Breast Cancer: Molecular Landscape and Future Challenges.
Guidi L, Pellizzari G, Tarantino P, Valenza C, et al · · 2023 · cited 51× · PMID 36831473 · DOI 10.3390/cancers15041130

Verify or expand the search:

Other trials of DS-8201a

Trials testing the same drug.

NCT04622319 — A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants W · Phase 3 · active not recruiting
NCT03368196 — DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein · Phase 1 · completed
NCT03384940 — DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01) · Phase 2 · completed
NCT03383692 — Study of DS-8201a for Participants With Advanced Solid Malignant Tumors · Phase 1 · completed
NCT03366428 — Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast C · Phase 1 · completed

Other recruiting trials for Breast Tumors

Currently open trials in the same condition.

NCT07209020 — HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery · NA · recruiting
NCT06805812 — Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormon · recruiting

Other UNICANCER trials

Trials by the same sponsor.

NCT07340619 — Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With · Phase 2 · not yet recruiting
NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test · Phase 3 · not yet recruiting
NCT07360834 — Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndr · NA · not yet recruiting
NCT07106632 — Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests · Phase 3 · not yet recruiting
NCT07294430 — Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate. · Phase 2 · 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 NCT04132960 (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 UNICANCER
Last refreshed: 12 June 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/NCT04132960.

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