Blood test could spot hidden cancer cells after breast cancer surgery
NCT ID NCT07136493
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to see if a blood test that looks for tiny pieces of tumor DNA (called ctDNA) could find leftover cancer cells in people with early-stage breast cancer after standard treatment. The goal was to help doctors decide who might need more therapy. However, the study was withdrawn before enrolling any participants, so no results are available.
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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.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Finished
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Jun 2026
- 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: * Documented written informed consent of the participant * Age ≥ 18 years * Diagnosis of stage I-III breast cancer (any gender) * Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed * Willingness to: * Provide blood samples * Provide archival tumor tissue sample (only necessary for Cohort 2 if analysis of surgical tissue was not successful) * Provide tumor tissue sample from resection/surgery (only necessary for Cohort 1 if analysis of surgical tissue was not successful) * Permit medical record review * Fall into one of the following categories defined below: Cohort 1, Subgroup A or B OR Cohort 2 * COHORT 1: Must have archival diagnostic tissue available * COHORT 1: Scheduled to undergo, but has not yet begun, neoadjuvant systemic therapy followed by curative resection * COHORT 1 (Subgroup A): HER2+ by current American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guidelines (any ER/PR status) * COHORT 1 (Subgroup B): Triple negative (ER, PR and HER2 negative). Defined as ER and PR ≤ 10% by immunohistochemistry (IHC) and HER2 negative, by current ASCO/CAP guidelines * COHORT 2: Scheduled to undergo upfront curative surgical resection with or without adjuvant chemotherapy followed by adjuvant endocrine therapy * COHORT 2: ER+/any PR/HER2- (ER positive defined as ER \> 10% by IHC) Exclusion Criteria: * Ductal carcinoma in situ * Inability to safely provide sequential blood samples * Prior or concurrent invasive malignancy (unless disease free \> 5 years) * An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager * A direct study team member * Inability to give informed consent
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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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CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338, United States
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City of Hope Atlanta Cancer Center
Newnan, Georgia, 30265, United States
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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City of Hope at Chicago
Zion, Illinois, 60099, United States
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City of Hope at Irvine Lennar
Irvine, California, 92618, United States
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