A blood test may spot breast cancer's return before symptoms appear
NCT ID NCT07718841
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This observational study is testing whether a blood test called a liquid biopsy can provide useful information for people with early-stage breast cancer who are about to start treatment before surgery. The test looks for tiny fragments of tumor DNA circulating in the blood. Researchers want to know if this test can help predict how the tumor will respond to treatment, detect any cancer left after treatment or surgery, and spot a recurrence earlier than standard scans. Participants will give blood samples at several time points while continuing their usual care.
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, liquid biopsy could become a standard tool to personalize breast cancer treatment and catch recurrence earlier.
- What could go wrong
- This is an observational study, not a treatment trial, so it will not directly test a new therapy. The results may not change practice immediately.
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.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2033
An estimate. End dates often move.
- Lead sponsor
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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.
Who is studied
The target population for inclusion in this study is BC patients scheduled to receive neoadjuvant treatment.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria: 1. Written informed consent prior to any specific study procedure. 2. Patients with willingness and ability to comply with study procedures. 3. Patients (women and men) ≥18 years of age. 4. Patients with a first diagnosis of the UICC (Union for International Cancer Control) stage I-III primary invasive BC whose tumors are of any of the following subtypes: * Luminal: Hormonal Receptor(HR)-positive and HER2-negative. * HER2-positive: HER2-positive regardless of the HR status. * Triple negative: Hormonal Receptor(HR)-negative and HER2-negative. HR and HER2 status should be based on local laboratory determination following the criteria of the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) international guidelines in effect at the time of testing. 5. Patients that are scheduled to receive NAT as determined by the treating physician according to standard clinical practice. 6. Archival Formalin-Fixed, Paraffin-Embedded (FFPE) sample of the primary tumor must be available to analyze tumor-informed ctDNA assays. Exclusion Criteria: 1. Patients with stage IV BC. 2. Patients with previous anti-cancer treatment for the current BC. 3. Patients with diagnosis of any other invasive malignancy in the 5 prior years, unless the malignancy has been treated with curative intent and is considered at low risk of recurrence, with no evidence of active disease at study entry. 4. Patients with a diagnosis of bilateral or multifocal breast tumors with different HR or HER2 status. 5. Patients with any severe acute or chronic medical or psychiatric condition or laboratory abnormality that 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. 6. Patients who are concurrently enrolled in clinical trials. 7. Females who are pregnant or breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Clínico Universitario San Carlos
Madrid, Madrid, 28040, Spain
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Hospital Clínico Universitario Virgen De la Victoria
Málaga, Málaga, 29010, Spain
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Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010, Spain
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Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28009, Spain
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Hospital Universitario Donostia
San Sebastián, Guipúzcoa, 20014, Spain
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Hospital Universitario Virgen Macarena
Seville, Sevilla, 41009, Spain
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Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013, Spain
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Hospital Universitario de Toledo
Toledo, Toledo, 45007, Spain
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Hospital del Mar
Barcelona, Barcelona, 08003, Spain
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Instituto Valenciano de Oncologia
Valencia, Valencia, 46009, Spain