Blood test may spot breast cancer recurrence years earlier
NCT ID NCT03357120
First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 2 times
Summary
This study is looking at whether tracking tiny bits of tumor DNA in the blood can help predict if breast cancer will come back after chemotherapy and surgery. Researchers will take blood samples from 180 people every 6 months for 5 years. The goal is to see if these DNA clues can warn of a relapse before symptoms appear.
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 simple blood test that helps doctors detect breast cancer recurrence earlier, potentially improving follow-up care.
- What could go wrong
- This is an observational study, not a treatment trial. It may not show a clear link between DNA mutations and recurrence, and results may not change current care for years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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120 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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Apr 2025
- 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.
- 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. Age ≥ 18 years (no age limit). 2. Women or men. 3. Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy): 1. Locally advanced tumor known to be inoperable from the start: * cT4a, b, c, d whatever the cN * or cN2 or cN3 whatever the cT. 2. Operable tumors: * cT2cN1 or cT3cN0 or cT3N1, * or cT2cN0 for which ganglionic invasion has been proven by cytology or histology. 4. Lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (M0). 5. Unilateral or bilateral breast cancer. Multifocality is accepted. 6. Patients who received 6 to 8 cycles of neoadjuvant chemotherapy. 7. Preoperative radiation therapy allowed. 8. Breast surgery performed and pathology report of a non-complete histological response (i.e. all the different results of ypT0 /is ypN0). 9. Signed informed consent. 10. Patients affiliated to a French social security scheme in accordance with Article 1121-11 of the French Code of Public Health. 11. Possible inclusion in another interventional research (surgical, radiotherapy or drug study). Exclusion Criteria : 1. cT2cN0 tumor without cytological or histological lymph node involvement. 2. Progression during neoadjuvant chemotherapy. 3. Exclusive neoadjuvant hormone therapy. 4. Complete blood transfusion within 120 days prior to 1st sampling. 5. History of invasive cancer regardless of the time elapsed since the diagnosis of this cancer, including a history of contralateral invasive breast cancer. However, patients who have been treated for in situ breast cancer, basocellular skin cancer or cervical cancer treated in situ are eligible. 6. Patient unable to follow and comply with research procedures for geographical, social or psychological reasons. 7. Patient deprived of liberty or subject to a legal protection measure.
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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.
Contacts and locations
Locations
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Institut Bergonie
Bordeaux, 33076, France
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Other studies related to the condition(s) this trial covers.
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