Cure My Disease

Don't miss your cure!

 Log in / Sign up

Scientists hunt for clues to predict T-DXd success in metastatic cancer

NCT ID NCT04257162

Knowledge-focused Sponsor: SOLTI Breast Cancer Research Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study collects tumor and blood samples from 180 people with metastatic cancer who are receiving or have received the drug T-DXd. Researchers will analyze these samples to find genetic markers that predict whether the drug will work well. The goal is to improve treatment decisions for future patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors predict which patients will benefit most from T-DXd, leading to more personalized treatment for metastatic cancer.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not change practice immediately and depend on sample quality and analysis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

A. Inclusion Criteria 1. Women and men ≥18 years old that has been included in a trial using Trastuzumab Deruxtecan (T-DXd; DS-8201a). 2. 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. 3. Patients who are starting, are receiving or have received treatment with Trastuzumab Deruxtecan as a treatment for metastatic/advanced cancer. 4. 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. 1. 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. 2. Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable. 5. Patients included before starting experimental treatment must be able and willing to provide blood sample(s). B. Exclusion Criteria 6. Not having participated or not willing to participate in a trial using Trastuzumab Deruxtecan. 7. Inability to comply with study and follow-up procedures

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic cancer

Contacts and locations

Locations

  • H.Univ. Arnau de Vilanova de Lleida

    Lleida, Lleida, Spain

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036, Spain

  • Hospital La Paz

    Madrid, Madrid, 28046, Spain

  • Hospital Universitari Vall d' Hebron

    Barcelona, Spain

  • Hospital Universitario 12 de octubre

    Madrid, Spain

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Canary Islands, 38320, Spain

  • Hospital Universitario de Jerez

    Jerez de la Frontera, Cadiz, 11407, Spain

  • Hospital Virgen de Macarena

    Seville, Sevilla, Spain

  • Hospital Virgen de la Victoria

    Málaga, Spain

  • Hospital del Mar

    Barcelona, Barcelona, 08003, Spain

  • ICO Badalona

    Badalona, Barcelona, Spain

  • ICO Hospitalet

    Barcelona, Spain

  • Instituto Valenciano de Oncología (IVO)

    Valencia, Valencia, 46009, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.