Clinical trial · Observational
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Longitudinal ctDNA Monitoring in Older Women With ER+ Breast Cancer Who Forego Upfront Surgery in Favor of Primary Endocrine Therapy
NCT05914792CI-TRIAL-00088446active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective study recruits patients with ER+/HER2-, non-metastatic breast cancer who omit upfront surgery in favor of primary endocrine therapy for sample collection and prospective circulating tumor DNA (ctDNA) measurement to guide disease surveillance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of ctDNA positivity
- timeFrame
- Up to 5 years
- description
- Proportion of patients with ER+/HER2- breast cancer who omit upfront surgery in favor of primary endocrine therapy who have any ctDNA positivity using Signatera assay.
Secondary outcomes (4)
- measure
- Progression-free survival (PFS)
- timeFrame
- Up to 5 years
- description
- The length of time after treatment initiation that patient is alive and without any evidence of tumor progression as defined by RECIST1.1 criteria. Per RECISIT v1.1: Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
- measure
- Breast cancer-specific survival (BCSS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * early-stage (stages I-III) breast cancer * estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) and HER2 receptor negative * able to provide blood samples * decision made by treating physician and patient to forego upfront surgery in favor of medical management with endocrine therapy * non-metastatic disease at diagnosis (patients need not have staging scans; patients at higher risk for de novo stage IV disease should not have any symptoms concerning for metastatic disease) * patients may be taking any endocrine therapy * patients may be taking any CDK4/6 inhibitor as deemed necessary by their treating physician * any ECOG Performance Status allowed * if patients have synchronous bilateral ER+ breast cancer, tissue from both sites should be submitted to Natera to perform ctDNA testing * patients with multifocal/multicentric tumors are eligible and the largest focus of cancer should be submitted for testing Exclusion Criteria: * under 70 years of age * breast cancer that is not estrogen receptor positive (ER+) or progesterone receptor (PR+) * unable to provide blood samples or insufficient tumor tissue for Signatera testing
References
Publications (0)
Data not yet available
No reference posted for this study.