Metastatic CancerHER2-PREDICTNCT04257162
HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)
A study testing Tumor and Blood sample collection in people with Metastatic Cancer, run by SOLTI Breast Cancer Research Group at 15 sites in Spain.
Trial summary
HER2-Predict is a multi-center, observational study using biological samples from patients treated with DS-8201a in the metastatic setting. Patients will provide a baseline FFPE tumor sample and additionally, blood sample for ctDNA determination will be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Tumor and Blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 15 sitesSpain
- Study dates
- 13 Dec 2019to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Inclusion Criteria
- Women and men ≥18 years old that has been included in a trial using Trastuzumab Deruxtecan (T-DXd; DS-8201a).
- The participant (or legally acceptable representative if applicable) provides written informed consent for the study. It is possible to include patients that were exitus during or after treatment by filling out the appendix 1 form and filing it into the patient's clinical chart.
- Patients who are starting, are receiving or have received treatment with Trastuzumab Deruxtecan as a treatment for metastatic/advanced cancer.
- Submission of a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block from the most recently collected tumor tissue, with an associated pathology report, for central molecular analysis and for other protocol-mandated secondary and exploratory assessments. If a newer specimen is either insufficient or unavailable, the patient may still be eligible if the patient can provide a tissue block (preferred) or is willing to consent to and undergo an additional pretreatment core or excisional biopsy (if it is assessable and the biopsy can be safely obtained). The tumor tissue should be of good quality and quantity based on total and viable tumor content.
- Acceptable samples include core needle biopsies of the deep metastatic lesion or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions or biopsies from bone metastases.
- Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable.
- Patients included before starting experimental treatment must be able and willing to provide blood sample(s).
- Exclusion Criteria
- Not having participated or not willing to participate in a trial using Trastuzumab Deruxtecan.
- Inability to comply with study and follow-up procedures
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
ICO Badalona
Badalona, Barcelona
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Hospital Universitari Vall d' Hebron
Barcelona
ICO Hospitalet
Barcelona
Hospital Universitario de Jerez
Jerez de la Frontera, Cadiz, 11407
H.Univ. Arnau de Vilanova de Lleida
Lleida, Lleida
Hospital La Paz
Madrid, Madrid, 28046
Hospital Universitario 12 de octubre
Madrid
Hospital Virgen de la Victoria
Málaga
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, 38320
Hospital Virgen de Macarena
Seville, Sevilla
Hospital Universitario Virgen del Rocio
Seville
Instituto Valenciano de Oncología (IVO)
Valencia, Valencia, 46009
About this study
HER2-Predict is a multi-center, observational study using biological samples from patients treated with DS-8201a in the metastatic setting. Patients will provide a baseline FFPE tumor sample and additionally, blood sample for ctDNA determination will be collected.
- Conditions
- Metastatic Cancer
- Being tested
- Tumor and Blood sample collection
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor and Blood sample collectionOther
This is a non-interventional protocol and does not provide study drug or specific requirements for how the patients should be treated.
Nevertheless, patients participating in T-DXd trials included in this study are those who were randomized to receive T-DXd.
Tumor sample and blood sample will be collected within the framework of HER2-Predict Study
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Other | Patients with metastatic cancer treated with Trastuzumab Deruxtecan (T-DXd; DS-8201a) Receives: Other: Tumor and Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start13 Dec 2019
- Primary completion30 Jun 2025
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257162
- Sponsor's protocol ID
- SOLTI-1804
- Other IDs
- 2019-002991-15, 2019
- Acronym
- HER2-PREDICT
- Status last verified
- Sep 2025
- First submitted
- 30 Jan 2020
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)
- ClinicalTrials.gov ID
- NCT04257162
- Acronym / sponsor ID
- HER2-PREDICT / SOLTI-1804
- Conditions
- Metastatic Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- SOLTI Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Daiichi Sankyo
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- May 2028 (estimated)
- First posted
- 5 Feb 2020 (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.
HER2-Predict is a multi-center, observational study using biological samples from patients treated with DS-8201a in the metastatic setting. Patients will provide a baseline FFPE tumor sample and additionally, blood sample for ctDNA determination will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Other | Other: Tumor and Blood sample collectionPatients with metastatic cancer treated with Trastuzumab Deruxtecan (T-DXd; DS-8201a) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Tumor and Blood sample collectionThis is a non-interventional protocol and does not provide study drug or specific requirements for how the patients should be treated. Nevertheless, patients participating in T-DXd trials included in this study are those who were randomized to receive T-DXd. Tumor sample and blood sample will be collected within the framework of HER2-Predict Study | Other | Experimental Arm |
Primary outcome
identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor and Blood sample collection in people with Metastatic Cancer, run by SOLTI Breast Cancer Research Group at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 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 Spain. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response (time frame: through study completion, an average of 1 year). 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 9 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.