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Breast TumorsPhase 2DAISYNCT04132960

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

A Phase 2 study testing DS-8201a in people with Breast Tumors, run by UNICANCER at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Tumors
What is being tested?
DS-8201a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
15 sitesFrance
Study dates
21 Oct 2019to 26 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have signed a written informed consent form prior to any study specific procedures. When the patient is physically unable to give his/her written consent, a trusted person of his/her choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
  • Female or male subjects aged ≥18 years.
  • Patient with histologically-confirmed diagnosis of invasive breast cancer. Tumors can be either HER2 immunohistochemistry (IHC)3+/in situ hybridization (ISH) positive or IHC2+/ISH positive or IHC2+/ISH negative or IHC1+ or IHC0+, of most recent tumor tissue sample available.
  • Patient with a documented radiologic metastatic progression.
  • Patient considered by the investigator as not amenable to any other validated therapeutic option, after at least 1 line of chemotherapy in metastatic setting. Patient must have been previously treated with anthracyclines and taxanes (in (neo-)adjuvant and/or metastatic setting). Additionally:
  • Patient with HER2 over-expressing (IHC3+ and IHC2+/ISH+) tumor must have been treated and have progressed on trastuzumab and on TDM-1. Prior treatment with pertuzumab is not required.
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  • Patient with HER2 negative (IHC0, 1+, and 2+/ISH-) and hormone receptor positive (estrogen receptor (ER)+ and/or progesterone receptor (PR)+) tumor must be resistant to endocrine therapy and CDK4/6 inhibitors, and must have been treated with capecitabine.
  • Non-bone metastatic site easily accessible to biopsy.
  • Presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
  • Patient with world health organization (WHO) performance status ≤1.
  • Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, and hemoglobin ≥9 g/dL (transfusion is not allowed within 1 week prior to baseline assessment).
  • Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range if no liver metastases or <3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤3 × ULN (AST and ALT≤ 5 ULN when documented liver metastasis).
  • Adequate blood clotting function: International Normalized Ratio (INR)/Prothrombin Time (PT) and activated Partial Thromboplastin Time (aPTT) ≤1.5 x ULN.
  • Adequate renal function: estimated creatinine clearance ≥30 mL/min according to the Cockcroft-Gault formula or serum creatinine ≤1.5 x ULN.
  • Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before inclusion.
  • Male and female subjects of reproductive/childbearing potential must agree to use of a highly effective contraception for subjects throughout the study and for at least 4.5 months after last study treatment administration if the risk of conception exists.
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrolment or urine pregnancy test 72 hours prior to enrolment.
  • Patient is willing to comply with 2 sequential tumor biopsies (baseline and at first progression), and with a series of blood samples throughout the study.
  • Patients must be affiliated to a Social Security System.

Who cannot join

  • Patient with a breast cancer amenable for resection or radiation therapy with curative intent.
  • Patient has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
  • Patient with bone metastatic disease only.
  • Patient with multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
  • Persistent unresolved toxicities with grade ≥2 (except alopecia and renal function). Subject with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor (eg, Grade 2 chemotherapy-induced neuropathy).
  • Patient receiving treatments such as chemotherapy (including antibody drug therapy, retinoid therapy, hormonal therapy) within 3 weeks before inclusion (within 2 weeks or 5 half-lives, whichever is longer, for small-molecule targeted agents, within 6 weeks for nitrosureas or mitomycin C), immunotherapy within 4 weeks before inclusion, radiotherapy within 4 weeks (if palliative stereotactic radiotherapy: within 2 weeks) or major surgery within 4 weeks. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation.
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  • Patient using drugs that could have pharmacokinetics interaction with investigational drugs. Concomitant use of strong CYP3A4 inhibitors or OATP 1B inhibitors should be avoided. If concomitant use of strong CYP3A4 or OATP 1B inhibitors is unavoidable, consider delaying DS-8201a treatment until the inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible. If a strong CYP3A4 inhibitor or an OATP 1B inhibitor is co-administered and DS-8201a treatment cannot be delayed, patients should be closely monitored for adverse reactions.
  • Patients with a concomitant use of chronic systemic (intravenous or oral) corticosteroids or other immunosuppressive medications except for managing adverse events (inhaled steroids or intra articular steroid injections are permitted in this study.) Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.
  • Patient with history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  • Patient with clinically significant corneal disease in the opinion of the Investigator.
  • Known prior severe hypersensitivity to investigational product or any component in its formulation, including known severe hypersensitivity reactions to study drug (National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade ≥3).
  • Patient has a history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Patients previously treated with topoisomerase 1 inhibitor.
  • Patient has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.
  • Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
  • Known active hepatitis B virus or hepatitis C virus infection at screening.
  • Active infection requiring systemic therapy (as intravenous antibiotics, antivirals, antifungals,…).
  • Other severe acute or chronic medical conditions or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Patient with a history of symptomatic congestive heart failure (New York Heart Association Class II to IV), serious cardiac arrhythmia requiring treatment, history of myocardial infarction or troponin levels consistent with myocardial infarction 28 days prior to inclusion, or unstable angina within 6 months prior to inclusion, or current dyspnea at rest due to advanced malignancy.
  • Patient with a corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (males) based on average of the screening triplicate12-lead electrocardiogram (ECG).
  • Pregnant women, women who are likely to become pregnant or are breastfeeding or women who want donate, or retrieve for their own use, ova from the time of screening and throughout the study and for at least 4.5 months after last study treatment administration.
  • Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  • Patient unwilling to participate to the biological investigations.
  • Individual deprived of liberty or placed under legal protection.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Institut Bergonié

    Bordeaux

  • Centre François Baclesse

    Caen

  • Centre Jean Perrin

    Clermont-Ferrand

  • Centre Hospitalier Universitaire Dupuytren

    Limoges

  • Centre Léon Bérard

    Lyon

  • Institut Paoli Calmettes

    Marseille

  • Centre Antoine Lacassagne

    Nice

  • Institut Curie

    Paris

  • Institut Jean Godinot

    Reims

  • Centre Eugène Marquis

    Rennes

  • Institut Curie - Hôpital Huguenin

    Saint-Cloud

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez

  • Institut de Cancérologie Strasbourg Europe (ICANS)

    Strasbourg

  • Institut Claudius Regaud

    Toulouse

  • Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC) for Advanced Breast Cancer Patients, With Biomarkers Analysis to Characterize Response/Resistance to Therapy

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

Read the detailed description

The main objective is to evaluate the anti-tumor activity of DS-8201a in three cohorts of advanced breast cancer patients:

  • Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+)
  • Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-)
  • Cohort 3: HER2 non-expressing (IHC0+)
Conditions
Breast Tumors
Being tested
DS-8201a
Keywords
DS-8201a, ADC, HER2, metastatic breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS-8201aDrug

    Anti-HER2-antibody drug conjugate (ADC)

Study groups in NCT04132960
Study groupRoleWhat they receive
HER2 statusExperimentalThree cohorts of advanced breast cancer patients: * Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+) * Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-) * Cohort 3: HER2 non-expressing (IHC0+)
Receives: Drug: DS-8201a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antitumor activity of DS-8201a in the 3 cohorts of patients

    The primary endpoint is antitumor activity of DS-8201a carried out by the determination of the confirmed best objective response (BOR) rate in each cohort. The BOR is defined as the presence of a confirmed partial or complete response observed on treatment, as assessed by investigators.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start21 Oct 2019
  3. Primary completion29 Oct 2021
  4. Study completion26 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The main objective is to evaluate the anti-tumor activity of DS-8201a in three cohorts of advanced breast cancer patients: * Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+) * Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-) * Cohort 3: HER2 non-expressing (IHC0+)
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04132960
Sponsor's protocol ID
UC-0105/1815
Other IDs
2018-004868-57, 2018
Acronym
DAISY
Status last verified
Jun 2025
First submitted
16 Oct 2019
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mosele F, Deluche E, Lusque A, Le Bescond L, Filleron T, Pradat Y, Ducoulombier A, Pistilli B, Bachelot T, Viret F, Levy C, Signolle N, Alfaro A, Tran DTN, Garberis IJ, Talbot H, Christodoulidis S, Vakalopoulou M, Droin N, Stourm A, Kobayashi M, Kakegawa T, Lacroix L, Saulnier P, Job B, Deloger M, Jimenez M, Mahier C, Baris V, Laplante P, Kannouche P, Marty V, Lacroix-Triki M, Dieras V, Andre F. Trastuzumab deruxtecan in metastatic breast cancer with variable HER2 expression: the phase 2 DAISY trial. Nat Med. 2023 Aug;29(8):2110-2120. doi: 10.1038/s41591-023-02478-2. Epub 2023 Jul 24.

    PubMed 37488289

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DS-8201a in people with Breast Tumors, run by UNICANCER at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antitumor activity of DS-8201a in the 3 cohorts of patients (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04132960, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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