HER2-positive Metastatic Breast CancerPhase 2ZEPHIR-02NCT06595563
HER2 Molecular Imaging With 89Zr-trastuzumab PET/CT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast Cancer
A Phase 2 study testing Trastuzumab emtansine in people with HER2-positive Metastatic Breast Cancer and HER2-positive Advanced Breast Cancer, run by Jules Bordet Institute at 8 sites in 2 countries.
Trial summary
ZEPHIR-02 is a multicentre, open-label phase II study that will enroll subjects with HER2-positive advanced/metastatic breast cancer (mBC) who have experienced disease progression under trastuzumab deruxtecan (T-DXd) in the metastatic setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Metastatic Breast Cancer, HER2-positive Advanced Breast Cancer
- What is being tested?
- Trastuzumab emtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 30 Jun 2026to 23 Jul 2026
- 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
- ECOG performance status ≤ 1
- Must have histologically or cytologically confirmed progressive advanced/metastatic HER2-positive breast carcinoma as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing. HER2 status may be determined in the primary breast cancer tumour or, when not available, in a metastatic lesion.
- Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed if all tested HER2-positive, according to local testing
- Prior treatment with taxane, trastuzumab and pertuzumab (early or advanced setting) and T-DXd (metastatic setting). In order to be eligible, patients subjects must have received T-DXd as the last systemic metastatic treatment line before inclusion, and presented disease progression on this drug.
- Prior therapy with tucatinib, trastuzumab, and capecitabine, in advanced setting, is permissible, provided that T-DXd serves as the last systemic metastatic treatment line before inclusion, and patient subject presented disease progression on this drug.
- Life expectancy ≥ 6 months.
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- At screening FDG-PET at least two "target" lesions are required to fulfil the following criteria: (1) anatomically transaxial diameter ≥ 1.5 cm and (2) metabolically assessable with a maximum standard uptake value corrected for lean body mass (SUVmax) ≥ 1.5 x SUVmean + 2 standard deviations (SD) of the liver measured in a 3-cm-diameter spherical volume of interest (VOI) in normal liver parenchyma.
- In case of suspected liver metastasis, a lesion should have a SUVmax ≥ 2 x SUVmean + 3 SD of the blood pool measured in a 1 cm-diameter VOI within descending thoracic aorta. Lesions pre-treated with irradiation are not eligible for consideration as "target" lesions.
- Adequate Bone Marrow Function including:
- Absolute Neutrophil Count (ANC) ≥1000/μL or ≥1x109/L.
- Platelets ≥100,000/μL or ≥ 100 x 109/L.
- Haemoglobin ≥ 9 g/dL.
- Adequate Renal Function including serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution.
- Adequate Liver Function, including all the following parameters:
- Total serum bilirubin ≤ 1.5 x ULN unless the patient subject has documented Gilbert syndrome.
- Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 2.5x ULN.
- Current left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography or multiple-gated acquisition scanning and no history of a LVEF < 40% or symptomatic heart failure or a recent myocardial infarction.
- Willingness to provide tumour tissue (mandatory biopsy) and blood samples (mandatory) for translational research activities.
- Willingness to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Affiliated to the French Social Security System
Who cannot join
- Prior exposure to T-DM1 for the treatment of metastatic BC. For subjects exposed to T-DM1 for the treatment of early BC, subjects must not have relapsed while on or within 12 months of finishing treatment with T-DM1.
- Brain metastasis as sole metastasis and/or symptomatic or requiring therapy to control symptoms.
- History of interstitial lung disease / pneumonitis (grade 3 or 4) during the prior treatment with T-DXd.
- Cardiopulmonary dysfunction as defined by any of the following:
- Significant symptoms (Grade ≥ 2) relating to LV dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy.
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
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- Inadequately controlled angina, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease
- Screening LVEF < 50% by either ECHO or MUGA
- History of NCI CTCAE (Version 4.0) Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria Class ≥ II
- History of a decrease in LVEF to < 40% or symptomatic CHF with prior trastuzumab treatment (e.g., during preoperative therapy)
- Myocardial infarction within 12 months prior to randomization
- Requirement for continuous oxygen therapy
- Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to trastuzumab or excipients.
- Contra-indication for treatment with T-DM1.
- The number of subjects included in this trial, considered as "rapid progressors" (Rapid progressors defined as progressive disease within the first 6 months of T-DXd therapy) will be capped at 10% at enrolment (no more than 7 subjects out the 78 subjects planned to be recruited). After the first 7 "rapid progressors" included, progression within the first 6 months of T-DXd therapy will be considered as an exclusion criterion.
- Any known liver disease, including known carriers of hepatitis B virus, hepatitis C, autoimmune hepatic disorders and sclerosing cholangitis.
- Concurrent, serious, uncontrolled infections or known infection with HIV. Prior history of other invasive cancer in the past 5 years except basal or squamous cell carcinoma of skin that has been definitively treated.
- Pregnant and/or lactating women, or intending to become pregnant during the study. Serum pregnancy test (for subjects of childbearing potential) positive within 15 days prior to enrolment.
- Women of childbearing potential refusing to use one highly effective method of contraception from ICF signature, during the course of the study and at least 7 months after the last administration of T-DM1.
- Men with childbearing potential partner refusing to use condom during the course of this study and for at least 7 months after the last administration of T-DM1.
- Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
- Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Belgium6 sites
Institut Jules Bordet
Anderlecht, Brussels Capital, 1070
CHU Charleroi - Marie Curie
Charleroi, 6042
UZ Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
CHU Liège
Liège, 4000
AZ Delta
Roeselare, 8800
Netherlands2 sites
VUMC Amsterdam
Amsterdam, 1081
UMC Groeningen
Groningen, 9713
About this study
ZEPHIR-02 is a multicentre, open-label phase II study that will enroll subjects with HER2-positive advanced/metastatic breast cancer (mBC) who have experienced disease progression under trastuzumab deruxtecan (T-DXd) in the metastatic setting.
All subjects will undergo baseline biopsy, blood collection, FDG-PET/CT and 89Zr-trastuzumab PET/CT (HER2-PET/CT) and will be classified as HER2-PET/CT positive or negative, as previously described in the ZEPHIR trial. Focusing on a central visual "patient-based" classification that captures the entire disease burden, a side-by-side display will be used, comparing baseline FDG-PET/CT (which identifies all FDG-positive metastases regardless of their HER2-imaging status) and HER2-PET/CT. Subjects will be categorized into two HER2-PET/CT patterns (positive vs. negative) based on proportion of FDG-avid tumor load with significant 89Zr-trastuzumab uptake.
Read more
Subjects classified as "positive" will receive T-DM1 as monotherapy, IV 3.6mg/kg every 3 weeks (21 days +- 3 days) until disease progression, unacceptable toxicity or request of the subject to withdraw from the study. FDG-PET/CT will be performed before cycle 2 of T-DM1 will serve as a research tool to correlate metabolic changes with clinical outcomes. Other FDG-PET/CT will be performed before cycle 4 of T-DM1 for assessment of response. Subjects who demonstrate a partial or complete response (responders) will continue treatment with T-DM1. Subjects who exhibit stable disease or disease progression (non-responders) will discontinue study treatment and enter the survival follow-up period. For responders, subsequent metabolic evaluations will be performed every 3 months, with FDG-PET/CT. Treatment response will be assessed according to metabolic response. For these subjects, mandatory blood samples will be obtained at all metabolic reassessments. Subjects with HER2-PET/CT classified as "negative" will receive treatment of physician's choice (TPC) as per the best local clinical practice and be out of the study.
All enrolled subjects will undergo a mandatory biopsy during the pre-treatment period.
The study also includes mandatory translational procedures (i.e. collection of tumour biopsy during pre-treatment period and blood samples at pre-specified time points) for exploratory molecular analyses.
Read the detailed description
ZEPHIR-02 is a multicentre, open-label phase II study that will enroll subjects with HER2-positive advanced/metastatic breast cancer (mBC) who have experienced disease progression under trastuzumab deruxtecan (T-DXd) in the metastatic setting.
All subjects will undergo baseline biopsy, blood collection, FDG-PET/CT and 89Zr-trastuzumab PET/CT (HER2-PET/CT) and will be classified as HER2-PET/CT positive or negative, as previously described in the ZEPHIR trial. Focusing on a central visual "patient-based" classification that captures the entire disease burden, a side-by-side display will be used, comparing baseline FDG-PET/CT (which identifies all FDG-positive metastases regardless of their HER2-imaging status) and HER2-PET/CT. Subjects will be categorized into two HER2-PET/CT patterns (positive vs. negative) based on proportion of FDG-avid tumour load with significant 89Zr-trastuzumab uptake. Lesion uptake will be considered significant/pertinent if it is visually higher than the local background.
- HER2-PET/CT positive pattern: The entire or majority of the tumour load shows significant tracer uptake.
- HER2-PET/CT negative pattern: The dominant part or all of the tumour load lacks significant tracer uptake.
Subjects classified as "positive" will receive T-DM1 as monotherapy, IV 3.6mg/kg every 3 weeks (21 days +- 3 days) until disease progression, unacceptable toxicity or request of the subject to withdraw from the study. FDG-PET/CT will be performed before cycle 2 of T-DM1 for early assessment of response and then again before cycle 4. At the early FDG-PET/CT assessment (before cycle 2), response assessment will be done using a cut-off of 15% based on the CONSIST criteria. Subjects who demonstrate a partial or complete response (responders) and will continue treatment with T-DM1. Subjects who exhibit stable disease or disease progression (non-responders) will discontinue study treatment and enter the survival follow-up period. For responders, subsequent metabolic evaluations will be performed every 3 months, with FDG-PET/CT. Treatment response will be assessed according to metabolic response. For these subjects, blood samples will be obtained at all metabolic reassessments (mandatory).
The subjects with HER2 PET/CT classified as "negative" will receive treatment of physician's choice (TPC) as per the best local clinical practice. Subsequent treatment will be collected and the subject will enter survival follow-up.
All enrolled subjects will undergo a mandatory biopsy during the pre-treatment period. Of note, results of DNA sequencing on the biopsy will be communicated to the treating oncologist, to potentially inform post progression therapy.
- Being tested
- Trastuzumab emtansine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab emtansineDrug
Also called T-DM1
T-DM1 will be administered IV at a dose of 3.6 mg/kg every 3 weeks. (21 days +/- 3 days) until disease progression, unacceptable toxicity or request of the subject to withdraw from the study. The total dose will depend on the subject's weight on day 1 of each T-DM1 cycle.
| Study group | Role | What they receive |
|---|---|---|
| HER2 PET/CT "positive" | Experimental | Subjects classified as HER2-PET/CT positive will receive T-DM1, IV 3.6mg/kg every 3 weeks, as monotherapy. HER2-PET/CT positive pattern: The entire or majority of the tumour load shows significant tracer uptake. Receives: Drug: Trastuzumab emtansine |
| HER2 PET/CT "negative" | No intervention | Subjects classified as HER2 PET/CT negative will receive treatment of physician's choice (TPC) as per the best local clinical practice. Subsequent treatment will be collected and the subject will enter survival follow-up. HER2-PET/CT negative pattern: The dominant part or all of the tumour load lacks significant tracer uptake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of genomic alterations and HER2 expression.
To characterize the tumour landscape (molecular alterations on tissue and HER2 expression and its heterogeneity) in HER2-positive mBC after at least 1 line of systemic therapy for advanced disease in order to better inform the oncologist and the subject regarding next treatment options.
Measured: Through study completion, up to 2 years
Time to treatment failure (TTF)
The time to treatment failure (TTF), defined as the time from T-DM1 start to discontinuation for any reason, including disease progression (clinical or image-based on 18FDG-PET/CT), treatment toxicity or death in participants classified as "positive" (per metabolic response).
Time to Treatment Failure (TTF) of subjects classified as "positive" and its survival probability measures (median survival, survival rate at month 6) will be estimated using Kaplan-Meier method
Measured: During study treatment period (from C1 of T-DM1 until discontinuation), up to 1 year on average
Secondary outcomes (4)
Overall Survival under T-DM1
The Overall survival (OS) defined from the start of treatment to the date of death from any cause (subjects classified as "positive") Overall survival (OS) of subjects classified as "positive" will be analysed as time-to-event study and estimated using Kaplan-Meier method
Measured: From study treatment period until death, up to 1 year on average
Duration of Response under T-DM1
The Duration of response (DoR) defined as the time from the date of first documentation of response (CR or PR) to disease progression or death, in participants who achieve complete or partial response assessed by metabolic response (participants classified as "positive") DoR of subjects classified as "positive" will also be analysed as time-to-event study and estimated using Kaplan-Meier method
Measured: During study treatment period until disease progression or death, up to 1 year on average
Disease Control Rate under T-DM1
The disease control rate (DCR) defined as absence of disease progression The DCR of subjects classified as "positive" will be described as proportion with two-sided 95% binomial proportion confidence intervals.
Measured: From study treatment period until disease progression or death, up to 1 year on average
Safety of T-DM1
Incidence, nature, and severity of adverse events, including but not limited to drug induced liver injury The intensity of all AEs will be graded according to the NCI-CTCAE version 5.0 on a five-point scale (Grade 1 to 5)
Measured: From study treatment period until progression disease, start of new anti-cancer treatment or death, up to 1 year on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Jun 2026
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
Why it stopped: Study logistics or limited study population, as defined by the iclusion/exclusion criteria, leading to a poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Martine Piccart, Md, PhD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595563
- Sponsor's protocol ID
- IJB-ZEPHIR02-2024
- Acronym
- ZEPHIR-02
- Status last verified
- Feb 2026
- First submitted
- 4 Sep 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER2 Molecular Imaging With 89Zr-trastuzumab PET/CT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT06595563
- Acronym / sponsor ID
- ZEPHIR-02 / IJB-ZEPHIR02-2024
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study logistics or limited study population, as defined by the iclusion/exclusion criteria, leading to a poor recruitment
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ZEPHIR-02 is a multicentre, open-label phase II study that will enroll subjects with HER2-positive advanced/metastatic breast cancer (mBC) who have experienced disease progression under trastuzumab deruxtecan (T-DXd) in the metastatic setting.
All subjects will undergo baseline biopsy, blood collection, FDG-PET/CT and 89Zr-trastuzumab PET/CT (HER2-PET/CT) and will be classified as HER2-PET/CT positive or negative, as previously described in the ZEPHIR trial. Focusing on a central visual "patient-based" classification that captures the entire disease burden, a side-by-side display will be used, comparing baseline FDG-PET/CT (which identifies all FDG-positive metastases regardless of their HER2-imaging status) and HER2-PET/CT. Subjects will be categorized into two HER2-PET/CT patterns (positive vs. negative) based on proportion of FDG-avid tumor load with significant 89Zr-trastuzumab uptake.
Subjects classified as "positive" will receive T-DM1 as monotherapy, IV 3.6mg/kg every 3 weeks (21 days +- 3 days) until disease progression, unacceptable toxicity or request of the subject to withdraw from the study. FDG-PET/CT will be performed before cycle 2 of T-DM1 will serve as a research tool to correlate metabolic changes with clinical outcomes. Other FDG-PET/CT will be performed before cycle 4 of T-DM1 for assessment of response. Subjects who demonstrate a partial or complete response (responders) will continue treatment with T-DM1. Subjects who exhibit stable disease or disease progression (non-responders) will discontinue study treatment and enter the survival follow-up period. For responders, subsequent metabolic evaluations will be performed every 3 months, with FDG-PET/CT. Treatment response will be assessed according to metabolic response. For these subjects, mandatory blood samples will be obtained at all metabolic reassessments. Subjects with HER2-PET/CT classified as "negative" will receive treatment of physician's choice (TPC) as per the best local clinical practice and be out of the study.
All enrolled subjects will undergo a mandatory biopsy during the pre-treatment period.
The study also includes mandatory translational procedures (i.e. collection of tumour biopsy during pre-treatment period and blood samples at pre-specified time points) for exploratory molecular analyses.
Detailed description
ZEPHIR-02 is a multicentre, open-label phase II study that will enroll subjects with HER2-positive advanced/metastatic breast cancer (mBC) who have experienced disease progression under trastuzumab deruxtecan (T-DXd) in the metastatic setting.
All subjects will undergo baseline biopsy, blood collection, FDG-PET/CT and 89Zr-trastuzumab PET/CT (HER2-PET/CT) and will be classified as HER2-PET/CT positive or negative, as previously described in the ZEPHIR trial. Focusing on a central visual "patient-based" classification that captures the entire disease burden, a side-by-side display will be used, comparing baseline FDG-PET/CT (which identifies all FDG-positive metastases regardless of their HER2-imaging status) and HER2-PET/CT. Subjects will be categorized into two HER2-PET/CT patterns (positive vs. negative) based on proportion of FDG-avid tumour load with significant 89Zr-trastuzumab uptake. Lesion uptake will be considered significant/pertinent if it is visually higher than the local background.
- HER2-PET/CT positive pattern: The entire or majority of the tumour load shows significant tracer uptake.
- HER2-PET/CT negative pattern: The dominant part or all of the tumour load lacks significant tracer uptake.
Subjects classified as "positive" will receive T-DM1 as monotherapy, IV 3.6mg/kg every 3 weeks (21 days +- 3 days) until disease progression, unacceptable toxicity or request of the subject to withdraw from the study. FDG-PET/CT will be performed before cycle 2 of T-DM1 for early assessment of response and then again before cycle 4. At the early FDG-PET/CT assessment (before cycle 2), response assessment will be done using a cut-off of 15% based on the CONSIST criteria. Subjects who demonstrate a partial or complete response (responders) and will continue treatment with T-DM1. Subjects who exhibit stable disease or disease progression (non-responders) will discontinue study treatment and enter the survival follow-up period. For responders, subsequent metabolic evaluations will be performed every 3 months, with FDG-PET/CT. Treatment response will be assessed according to metabolic response. For these subjects, blood samples will be obtained at all metabolic reassessments (mandatory).
The subjects with HER2 PET/CT classified as "negative" will receive treatment of physician's choice (TPC) as per the best local clinical practice. Subsequent treatment will be collected and the subject will enter survival follow-up.
All enrolled subjects will undergo a mandatory biopsy during the pre-treatment period. Of note, results of DNA sequencing on the biopsy will be communicated to the treating oncologist, to potentially inform post progression therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2 PET/CT "positive" | Experimental | Drug: Trastuzumab emtansineSubjects classified as HER2-PET/CT positive will receive T-DM1, IV 3.6mg/kg every 3 weeks, as monotherapy. HER2-PET/CT positive pattern: The entire or majority of the tumour load shows significant tracer uptake. |
| HER2 PET/CT "negative" | No intervention | –Subjects classified as HER2 PET/CT negative will receive treatment of physician's choice (TPC) as per the best local clinical practice. Subsequent treatment will be collected and the subject will enter survival follow-up. HER2-PET/CT negative pattern: The dominant part or all of the tumour load lacks significant tracer uptake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- ECOG performance status ≤ 1
- Must have histologically or cytologically confirmed progressive advanced/metastatic HER2-positive breast carcinoma as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing. HER2 status may be determined in the primary breast cancer tumour or, when not available, in a metastatic lesion.
- Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed if all tested HER2-positive, according to local testing
- Prior treatment with taxane, trastuzumab and pertuzumab (early or advanced setting) and T-DXd (metastatic setting). In order to be eligible, patients subjects must have received T-DXd as the last systemic metastatic treatment line before inclusion, and presented disease progression on this drug.
- Prior therapy with tucatinib, trastuzumab, and capecitabine, in advanced setting, is permissible, provided that T-DXd serves as the last systemic metastatic treatment line before inclusion, and patient subject presented disease progression on this drug.
Key exclusion criteria (22 listed)
- Prior exposure to T-DM1 for the treatment of metastatic BC. For subjects exposed to T-DM1 for the treatment of early BC, subjects must not have relapsed while on or within 12 months of finishing treatment with T-DM1.
- Brain metastasis as sole metastasis and/or symptomatic or requiring therapy to control symptoms.
- History of interstitial lung disease / pneumonitis (grade 3 or 4) during the prior treatment with T-DXd.
- Cardiopulmonary dysfunction as defined by any of the following:
- Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to trastuzumab or excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab emtansineAlso: T-DM1T-DM1 will be administered IV at a dose of 3.6 mg/kg every 3 weeks. (21 days +/- 3 days) until disease progression, unacceptable toxicity or request of the subject to withdraw from the study. The total dose will depend on the subject's weight on day 1 of each T-DM1 cycle. | Drug | HER2 PET/CT "positive" |
Primary outcome
Characterization of genomic alterations and HER2 expression.
Time frame: Through study completion, up to 2 years
To characterize the tumour landscape (molecular alterations on tissue and HER2 expression and its heterogeneity) in HER2-positive mBC after at least 1 line of systemic therapy for advanced disease in order to better inform the oncologist and the subject regarding next treatment options.
Time to treatment failure (TTF)
Time frame: During study treatment period (from C1 of T-DM1 until discontinuation), up to 1 year on average
The time to treatment failure (TTF), defined as the time from T-DM1 start to discontinuation for any reason, including disease progression (clinical or image-based on 18FDG-PET/CT), treatment toxicity or death in participants classified as "positive" (per metabolic response). Time to Treatment Failure (TTF) of subjects classified as "positive" and its survival probability measures (median survival, survival rate at month 6) will be estimated using Kaplan-Meier method
4 secondary outcomes
Overall Survival under T-DM1
Time frame: From study treatment period until death, up to 1 year on average
Duration of Response under T-DM1
Time frame: During study treatment period until disease progression or death, up to 1 year on average
Disease Control Rate under T-DM1
Time frame: From study treatment period until disease progression or death, up to 1 year on average
Safety of T-DM1
Time frame: From study treatment period until progression disease, start of new anti-cancer treatment or death, up to 1 year on average
Results and safety
The study was stopped early (reason given: Study logistics or limited study population, as defined by the iclusion/exclusion criteria, leading to a poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Piccart, Md, PhD study chair
Jules Bordet Institute
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab emtansine in people with HER2-positive Metastatic Breast Cancer and HER2-positive Advanced Breast Cancer, run by Jules Bordet Institute at 8 sites in 2 countries.
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 21 inclusion and 22 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: stopped early, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Netherlands. 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 was stopped early (reason given: Study logistics or limited study population, as defined by the iclusion/exclusion criteria, leading to a poor recruitment). Results are not available in the source record.
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?
Characterization of genomic alterations and HER2 expression. (time frame: Through study completion, up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.