Clinical trial · Observational
Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer
LCCC 1642: Plasma Circulating Tumor DNA (ctDNA) Analyses in ER+ Metastatic Breast Cancer
NCT03161834CI-TRIAL-00051937withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB Study Closure
Summary
Brief summary (as posted)
The purpose of this study is to evaluate whether increased mutant ESR1 allele fraction in plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with ER+ metastatic breast cancer.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free Survival Prediction
- timeFrame
- Through study completion, an average of 3-6 weeks
- description
- To evaluate whether increased mutant ESR1 allele fraction in plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with ER+ metastatic breast cancer.
Secondary outcomes (2)
- measure
- DNA Analysis of Hotspot Mutation Prevalence
- timeFrame
- Through study completion, an average of 3-6 weeks
- description
- To evaluate the overall spectrum and prevalence of hotspot and non-hotspot ESR1 mutations in plasma ctDNA prior to initiating 2nd, 3rd, or 4th endocrine therapy and after clinical disease progression.
- measure
- DNA Analysis of Mutation and Radiographic Response Correlation
- timeFrame
- Through study completion, an average of 3-6 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years of age * Female gender * Biopsy proven diagnosis of breast cancer * Stage IV disease diagnosed either by radiographic studies or biopsy * ER+ by immunohistochemistry on primary and/or metastatic tissue biopsy (\>10%) * HER2 non-amplified (1+ or below by immunohistochemistry, and/or Her2 FISH \<2 HER2-to-CEP17 ratio) * Progressed on at least one prior line of endocrine therapy for metastatic disease * Three or fewer prior endocrine-containing therapies for recurrent/metastatic disease * Two or fewer prior lines of cytotoxic chemotherapy for recurrent/metastatic disease * Plans to initiate 2nd, 3rd, or 4th line endocrine therapy for metastatic disease * Recent re-staging scans within 4 weeks of study enrollment, with radiographically identifiable disease * No concurrent or prior diagnosis of malignancy other than breast cancer for the past 5 years. Patients with a history of in situ cancer or basal or localized squamous cell skin cancer remain eligible * Intends to pursue treatment as well as clinical and radiographic follow-up at UNC Health Care * Signed an institutional review board (IRB)-approved informed consent document for this protocol and HIPAA consent form Exclusion Criteria: * \< 18 years of age * Tissue biopsies that support the presence of both ER+ and ER- metastatic breast cancer in the same patient * Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.