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Circulating Tumor DNA

StatusRecruiting
PhasePhase 2
Started2025-09-30
View on ClinicalTrials.gov ↗

Amendment history

2026-06-25
minor
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 7 sites
2026-05-11
minor
Study Status, Eligibility, Contacts/Locations v11
Eligibility criteria-81 characters
Inclusion Criteria for Screening: Women or menAdults aged 18 years and older. Previous diagnosis of anatomic sta [...] at least five half-lives prior to initiation of elacestrant (refer section 9.9 of the protocol for prohibited concomitant medications). Participants who are pregnant. Inclusion Criteria for Trea [...]
Study sitesdetails revised at 1 of 7 sites
2026-04-26
minor
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 7 sites
2026-03-25
minor
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 7 sites
2026-03-12
minor
Study Status, Contacts/Locations v8
Study sites1→7
Show 7 earlier versions
2025-12-18
minor
Study Status, Outcome Measures v7
Secondary endpoints7 to 8 entries
Assessing AmDTx-MBCS' Impact on Decreasing Fear of Recurrence Scores
2025-11-10
minor
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v6
Eligibility criteria+3,738 characters
Inclusion Criteria for Screening: Women or men aged 18 years and older. Previous diagnosis o [...] with or without progesterone receptor positivity. Patients who arewith PR positive but ER-negative are not eligible. Participants [...] ER2- breast cancer at least five years ago and no more than 1520 years ago and must have completed adjuvant endocrine therapy. Participants must be off endocrine therapy for at least sixfour monthsweeks prior to screening. Exclusion Criteria for Screening: Known current metastatic disease. Known contraindication t [...] art receiving therapy on another therapeutic clinical trial. C [...]
Secondary endpoints6 to 7 entries
Patient-Reported Outcomes, Fear of Recurrence and Anxiety Levels During Elacestrant Treatment Diet and Physical Activity Levels in Breast Cancer Patients
Study description+163 characters
[...] be ctDNA tested every six months and monitored for one year. If andpatients willremain bectDNA allowedpositive at the completion of 12 months of study treatment, since they remain at increased risk of recurrence, they can choose to continue on elacestrant for an additional year12 months for a maximum of 24 months, they may also resume standard endocrine therapy, or continue with standard of care surveillance during follow up.
Study sitescontacts updated at 1 of 1 site
Study title-38 characters
ctDNACirculating GuidedTumor Adjuvant Treatment With Elacestrant: TBCRC-068DNA
2025-10-06
minor
Study Status v5
Start dateestimated 2025-09→confirmed 2025-09-30
2025-08-26
minor
Study Status v4
Primary completion date2027-07→2027-09
Completion date2027-07→2027-09
Start date2025-07→2025-09
2025-07-28
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-07-09
minor
Study Status v2
Primary completion date2027-06→2027-07
Completion date2027-06→2027-07
Start date2025-06→2025-07
2025-06-05
minor
Study Identification, Study Status v1
Primary completion date2027-04→2027-06
Completion date2027-04→2027-06
Start date2025-04→2025-06
Study title+27 characters
CirculatingctDNA TumorGuided DNAAdjuvant Treatment With Elacestrant: TBCRC-068
2025-04-03
minor
Original filing
487 trials monitored
See 35 trials at risk
5,180 trials monitored
See 256 trials at risk
This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Our trial will proceed in three separate phases: screening, treatment, and follow-up.
Trial Details
NCT Number NCT06923527
Lead Sponsor Yale University
Collaborators: Johns Hopkins University, Stemline Therapeutics, Inc., Personalis Inc.
Conditions ER+ Breast Cancer
Enrollment 50 participants
Start Date 2025-09-30
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-21