Circulating Tumor DNA

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06923527
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • ER+ Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elacestrant — DRUG
    Administration of elacestrant will follow the FDA approved dose and schedule for patients with ER+ metastatic breast cancer. Elacestrant 345 mg will be administered orally once daily for 12 cycles or until disease progression or unacceptable toxicity. The pills shall be administered with food (to reduce nausea and vomiting) at approximately the same time each day, and the prescription will be provided with the standard "Swallow tablets whole; do not chew, crush, or split" warning label.

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Administration of elacestrant will follow the FDA approved dose and schedule for patients with ER+ metastatic breast cancer. Elacestrant 345 mg will be administered orally once daily for 12 cycles or until disease progression or unacceptable toxicity

Primary Outcome Measure

Assessing Elacestrant's Impact on ctDNA Clearance in ER+HER2- Breast Cancer Patients [ Time Frame: Every 3 months during the treatment phase and at 3-month intervals for 12 months following the end of treatment ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Carl Brown
[email protected]
2037854095
Mariya Rozenblit, MD (PRINCIPAL_INVESTIGATOR)
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington D.C.District of Columbia20007
Lana Kheir
[email protected]
202-444-2223
Katia Khoury, MD (PRINCIPAL_INVESTIGATOR)
Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimoreMaryland21287
Sharon White
[email protected]
410-614-1361
Jenna Canzoniero, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Ilana Schlam Camhi, MD MPH
[email protected]
8773387425
Ilana M Schlam Camhi, MD MPH (PRINCIPAL_INVESTIGATOR)
Montefiore Einstein Comprehensive Cancer CenterThe BronxNew York10461
Fernando Gonterman
[email protected]
718-405-8126
Jesus Anampa, MD (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Joshua Plassmeyer, 412-648-6417
[email protected]
Julia Foldi, MD PhD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Pamela Lewis
[email protected]
713-563-4527
Carlos H Barcenas, MD MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTLombardi Comprehensive Cancer Center at Georgetown University Medical Center· Washington D.C., DCSidney Kimmel Comprehensive Cancer Center at John Hopkins· Baltimore, MDDana-Farber Cancer Institute· Boston, MAMontefiore Einstein Comprehensive Cancer Center· The Bronx, NYUPMC Hillman Cancer Center· Pittsburgh, PA

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