Clinical trial · Interventional
Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer
Evaluation of Circulating Tumor DNA Based Minimal Residual Disease Detection in Early Stage Breast Cancer Patients: A Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding This study has been closed at City of Hope at the request of the Sponsor due to delays and changes in study timeline.
Summary
Brief summary (as posted)
This clinical trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) based minimal residual disease (MRD) detection works for patients with early-stage breast cancer. MRD refers to a very small number of tumor cells that remain in the body during or after treatment. ctDNA refers to small pieces of DNA that are released into a person's blood by tumor cells as they die. Management of patients after cancer surgery remains a clinical dilemma, particularly for cancer detected at earlier stages as many patients are cured by surgery alone. This results in very large clinical trials required to demonstrate a modest benefit from treatment. Using ctDNA MRD testing in early-stage breast cancer patients receiving standard treatment may help researchers identify groups that would benefit from additional therapy, leading to better outcomes.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Estrogen Receptor-Positive Breast Carcinoma | Estrogen Receptor-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| HER2-Negative Breast Carcinoma | HER2-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| HER2-Positive Breast Carcinoma | HER2-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Triple-Negative Breast Carcinoma | Triple-Negative Breast Carcinoma | ONTOLOGY_EXACT |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1 (blood collection for ctDNA testing - 1)
- description
- Patients undergo collection of blood samples for ctDNA testing at 14-21 days post cycle 1, day 1 of SOC neoadjuvant chemotherapy, on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
- Other: Survey Administration
- type
- EXPERIMENTAL
- label
- Cohort 2 (blood collection for ctDNA testing -2)
- description
- Patients undergo collection of blood samples for ctDNA testing on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available