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Breast Cancer Stage IVPhase 2TUXEDO-1NCT04752059

Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases

A Phase 2 study testing Trastuzumab deruxtecan in people with Breast Cancer Stage IV, run by Medical University of Vienna at 1 site in Austria.

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

Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Breast Cancer Stage IV
What is being tested?
Trastuzumab deruxtecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteAustria
Study dates
28 Jul 2020to 1 May 2023
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 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed breast cancer
  • Radiologically documented metastatic disease
  • HER2-positive as defined by IHC 3+ and/or HER2/neu gene amplification
  • Newly diagnosed brain metastases or brain metastases progressing after prior local therapy
  • Measurable disease (RANO-BM criteria)
  • No indication for immediate local treatment
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  • No indication of leptomeningeal disease
  • KPS >70%, ECOG <2
  • Indication for systemic anti-HER2 treatment
  • Prior exposure to trastuzumab and pertuzumab
  • Prior exposure to T-DM1 allowed
  • Life expectancy of at least 3 months
  • Age ≥18 years
  • Patient must be able to tolerate therapy, and have adequate cardiac function (defined by baseline left ventricular ejection fraction ≥50%) Adequate bone-marrow, liver and kidney function
  • Adequate treatment washout period before enrolment, defined as:
  • Major Surgery: ≥4 weeks
  • Radiation therapy: ≥4 weeks
  • Chemotherapy, small-molecule targeted agents, anticancer hormonal therapy: ≥3 weeks
  • Antibody-based treatment: ≥4 weeks
  • Patient must be capable of understanding the purpose of the study and have given written informed consent

Who cannot join

  • Metastatic breast cancer other than HER2-positve disease
  • Use of any investigational agent within 28 days prior to initiation of treatment
  • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years including contralateral breast cancer
  • Major surgery, other than diagnostic surgery, within the last 4 weeks
  • Indication for immediate local therapy as defined by local standard
  • Leptomeningeal involvement
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  • Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment
  • Concomitant radiotherapy
  • Prior radiotherapy to the thorax other than breast irradiation or irradiation of bone metastases
  • A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), left ventricular ejection fraction <50%, arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval >450 ms)
  • Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) including acute and chronic infections with hepatitis B and C
  • Inadequate haematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands) <1.0 x 109/L; platelets <100 x 109/L
  • Inadequate kidney function: serum-creatinine >1.5 times upper normal Limit Hepatic dysfunction: total bilirubin >1.5 times upper normal limit (>3 in patients with liver metastases or known history of Gilbert's disease); ALT, AST >3 times TUXEDO-1_Version 2.0 05.05.2020 Page 8 of 73 upper normal limit (>5 in patients with liver metastases); serum albumin <2.5 g/dL; INR ≥1.5
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrolment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (i.e. rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), or prior pneumonectomy.
  • Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
  • Patients with active opportunistic infections
  • Known HIV infection
  • Concomitant treatment with chloroquine or hydroxychloroquine
  • Pregnant or lactating women. Women with childbearing potential must have a negative pregnancy test at screening
  • Women with childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Acceptable contraception methods included the application of an intrauterine device, barrier method or total abstinence
  • Patients with known hypersensitivity to trastuzumab
  • Patients not able to provide written informed consent Patients with known substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results
  • Patients requiring concomitant use of chronic systemic (IV or oral) corticosteroids at doses higher than 4 mg dexamethasone per day or other immunosuppressive medications except for managing adverse events (inhaled steroids or intra articular steroid injections are permitted in this study)

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • AKH Universitaetsklinikum Vienna, Department f. Internal medicine I, oncology

    Vienna, 1090

Other trials in Austria

About this study

Official title: Phase II Study of Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases

Read the detailed description

T-DXd will be administered at a dose of 5.4 mg/kg body weight once every three weeks in patients with newly diagnosed or progressive HER2 positive breast cancer brain metastases. Response rate by RANO-BM is defined the primary study endpoint.

Being tested
Trastuzumab deruxtecan
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Trastuzumab deruxtecanDrug

    Also called Ds8201a, Enhertu

    Trastuzumab-deruxtecan 5.4 mg/kg body weight i.v. on day 1 once every three weeks until progression or death

Study groups in NCT04752059
Study groupRoleWhat they receive
T-DXd 5.4 mgExperimentalSingle arm phase II trial
Receives: Drug: Trastuzumab deruxtecan

What is being measured

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

  1. Reponse rate of brain metastases to trastuzumab-deruxtecan

    measured according to RANO-BM criteria

    Measured: From date of randomization until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed up to 36 months

Secondary outcomes (3)

  1. Progression-free survival

    Time from inclusion until progression

    Measured: From date of randomization until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed up to 36 months

  2. Overall Survival

    Time from inclusion until death of any cause

    Measured: From date of randomization until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed up to 36 months

  3. Safety of trastuzumab deruxtecan in patients with active brain metastases

    Assessment of treatment-emerging adverse events

    Measured: From date of randomization until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed up to 36 months

Timeline

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

  1. First posted12 Feb 2021
  2. Study start28 Jul 2020
  3. Primary completion1 May 2023
  4. Study completion1 May 2023

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
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752059
Sponsor's protocol ID
TUXEDO-1
Acronym
TUXEDO-1
Status last verified
May 2023
First submitted
26 Jan 2021
Last updated
12 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bartsch R, Berghoff AS, Furtner J, Marhold M, Bergen ES, Roider-Schur S, Starzer AM, Forstner H, Rottenmanner B, Dieckmann K, Bago-Horvath Z, Haslacher H, Widhalm G, Ilhan-Mutlu A, Minichsdorfer C, Fuereder T, Szekeres T, Oehler L, Gruenberger B, Singer CF, Weltermann A, Puhr R, Preusser M. Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial. Nat Med. 2022 Sep;28(9):1840-1847. doi: 10.1038/s41591-022-01935-8. Epub 2022 Aug 8.

    PubMed 35941372

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab deruxtecan in people with Breast Cancer Stage IV, run by Medical University of Vienna at 1 site in Austria.

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 20 inclusion and 23 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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?

Reponse rate of brain metastases to trastuzumab-deruxtecan (time frame: From date of randomization until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed up to 36 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 NCT04752059, 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 May 2023.

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