Blood test may reveal if breast cancer treatment is working
NCT ID NCT07662252
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether tracking tumor DNA in the blood (ctDNA) can help doctors see how well breast cancer treatment is working before surgery. It will include 186 people with stage II-III HER2-positive or triple-negative breast cancer. Researchers will take blood samples at key points during standard treatment to see how quickly the tumor DNA disappears.
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 could lead to a blood test that helps doctors quickly tell if breast cancer treatment is working, allowing them to adjust therapy sooner.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly improve outcomes. The findings may not apply to all patients or lead to a usable test.
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 186 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
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 study population consists of female adult patients with newly diagnosed, histologically confirmed stage II-III HER2-positive or triple-negative breast cancer who are candidates for standard neoadjuvant therapy. Participants are selected and recruited from patients consecutively presenting to the outpatient oncology clinics and multidisciplinary breast cancer units at the University Hospital Federico II (Naples, Italy) and participating clinical centers. The cohort represents a real-world sample of patients undergoing routine clinical workup and standard-of-care neoadjuvant treatment regimens before scheduled surgical intervention.
- Ages
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18 years and older
- Sex
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Female participants only
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: * Patients with documented stage II-III HER2+ or TNBC and fit candidates for NAT. 2. In TNBC group, confirmed negative ER, PR and HER2 disease by local testing on primary disease specimen: tumor must be negative ER, PR, and HER2 defined by immunohistochemistry (IHC) according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing (Allison et al., 2020; Wolff et al., 2023). 3. In HER2+ group, Confirmed HER2+ disease by local testing on primary disease specimen: tumour must be HER2+ according to ASCO/CAP 2023 guidelines for HER2 testing (Wolff et al., 2023). 4. Patients with measurable disease; Patients with multifocal or multicentric breast cancer with at least one tumor lesion ≥1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathological criteria for TNBC and HER2+. 5. No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. 6. Patients with breast cancer are eligible for surgery. 7. Eastern Cooperative Oncology Group (ECOG) performance status≤2. Exclusion Criteria: * 1\. Patients with bilateral invasive BC. 2. Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1\_cN2a). 3\. Patients with inflammatory BC. 4. Patients with a known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis. 5. Patients with a history of invasive BC, ductal carcinoma in situ or lobular carcinoma in situ, and other malignancy within 5 years prior to screening. 6. Patients with a documented history of haemorrhagic diathesis, coagulopathy, or thromboembolism. 7. Patients with known allergy or hypersensitivity to any of the study drugs or any of their excipients. 8. Patients with history of non-compliance to medical regimens. 9. Patients refusing to perform liquid and tissue biopsy. 10. Patients unwilling to or unable to comply with the protocol. 11. Patients having had major surgery within 14 days prior to screening. 12. Pregnant or lactating females prior to treatment. 13. Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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