Trial · NCT07910565
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC)
NCT07910565, Not applicable, Not yet recruiting, Yale University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC). Trials, record NCT07910565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07910565
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC)
- NCT number
- NCT07910565
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 155 participants, estimated
- Lead sponsor
- Yale University
- Conditions
- Breast Cancer, Metastatic Breast Cancer, HR+/HER- Metastatic Breast Cancer
- Interventions
- FoundationOne® Liquid CDx (F1LCDx), Reflex tissue biopsy
- First posted
- 2026-11-02
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with ESR1 mutations detected by reflex tissue NGS | From enrollment through study completion (up to 5 years) | Among participants with an indeterminate-negative liquid biopsy result (negative for ESR1 mutations and ctDNA tumor fraction below 1%), measure the number of participants with an ESR1 mutation detected by reflex tissue NGS performed according to the study algorithm. |
| Secondary | Progression-free survival (PFS) | Up to 2 years after positive ESR1 mutation detection | Time from initiation of the first selective estrogen receptor degrader (SERD) after ESR1 mutation detection until objective disease progression, assessed using RECIST version 1.1 when available, or death from any cause, whichever occurs first. |
| Secondary | Rate of ESR1 mutation detection by liquid biopsy and ctDNA tumor fraction | Throughout the study, up to 5 years | Rate of ESR1 mutation detection by FoundationOne Liquid CDx (F1LCDx), stratified by ctDNA tumor fraction below 1% versus 1% or greater. |
| Secondary | Reflex Tissue NGS testing rate | Within the reflex testing time frame during the study, up to 5 years | Number of participants with an indeterminate-negative liquid biopsy result who undergo reflex tissue biopsy and NGS within the protocol-defined timeframe. |
| Secondary | Number participants initiating Selective Estrogen Receptor Degraders (SERD) therapy | Throughout the study, up to 5 years | Number participants initiating SERD therapy after ESR1 mutation detection |
| Secondary | Number participants SERD therapy by SERD agent | Throughout the study, up to 5 years | Number participants initiating SERD therapy after ESR1 mutation detection. Report counts by SERD agent, with FDA-approved SERDs grouped by class as applicable. |
| Secondary | Actionable genomic alterations detected by liquid biopsy and tissue NGS. | Throughout the study, up to 5 years | Rtes of actionable genomic alterations detected by F1LCDx and tissue NGS. |
| Secondary | Other genomic alterations detected at disease progression | At disease progression during the study, up to 5 years | Rates of driver and acquired genomic alterations detected at progression by F1LCDx or tissue NGS that were absent from prior tissue comprehensive genomic profiling (CGP). Acquired alterations are those absent from tissue CGP at diagnosis but newly detected at progression. |
| Secondary | Correlation of HRR gene findings with variant origin and germline confirmation | During the study, when the relevant genomic and confirmatory testing results are available, up to 5 years | Assess the relationship between homologous recombination repair (HRR) gene detection, variant origin prediction, germline banner classification when F1LCDx is performed, and confirmation of germline alterations by orthogonal testing. |
| Secondary | Correlation of HER2 status with ERBB2 copy number | During the study, when the relevant HER2 status and genomic results are available, up to 5 years | Assess the relationship between HER2-low or HER2-negative status and ERBB2 copy number results when F1CDx is performed. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07910565
GET https://conductscience.org/api/trials/v1/NCT07910565/registered