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New treatment option for ER+ Breast Cancer
Official title Circulating Tumor DNA
ClinicalTrials.gov ID: NCT06923527
What this study is testing
What is Elacestrant?
Elacestrant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for er+ breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for Screening:
- Adults aged 18 years and older.
- Previous diagnosis of anatomic stage IIB or anatomic stage III histopathologically or cytologically confirmed ER+, HER2-, breast cancer per local...
- Participants must have been diagnosed with ER+HER2- breast cancer at least five years ago and no more than 20 years ago and must have completed...
- Participants must be off endocrine therapy for at least four weeks prior to screening.
You likely can't join if
- for Screening:
- Known current metastatic disease.
- Known contraindication to receiving elacestrant as per FDA package insert.
- Current treatment with endocrine therapy.
- Prior treatment with elacestrant or other investigational SERDs.
- Current or past invasive cancer other than breast cancer, except:
See the full eligibility criteria
- for Screening:
- Adults aged 18 years and older.
- Previous diagnosis of anatomic stage IIB or anatomic stage III histopathologically or cytologically confirmed ER+, HER2-, breast cancer per local laboratory as per ASCO/CAP guidelines. In the context of this trial, ER...
- Participants must have been diagnosed with ER+HER2- breast cancer at least five years ago and no more than 20 years ago and must have completed adjuvant endocrine therapy.
- Participants must be off endocrine therapy for at least four weeks prior to screening.
- for Screening:
- Known current metastatic disease.
- Known contraindication to receiving elacestrant as per FDA package insert.
- Current treatment with endocrine therapy.
- Prior treatment with elacestrant or other investigational SERDs.
- Current or past invasive cancer other than breast cancer, except:
- Adequately treated basal or squamous cell carcinoma of the skin.
- Cancer survivors of previously diagnosed invasive cancer who were treated with curative intent and have no evidence of disease recurrence for five years or more and are considered low risk for future recurrence by the...
- Patients in the screening phase, or in the assigned by chance trial (treatment phase), cannot start receiving therapy on another therapeutic clinical trial.
- Current use of strong and moderate CYP3A4 inducers/inhibitors or other prohibited concomitant medication unless an acceptable substitute is available, and the prohibited medication is discontinued at least five...
- Participants who are pregnant. Inclusion Criteria for Treatment:
- ctDNA positivity by NEXT Personal assay.
- No evidence of metastatic disease on staging scans. a. If imaging, after review with a radiologist, is low probability for metastatic disease, patients may proceed with enrollment. Patients with suspicious but...
- At the time of informed consent signature for treatment, participants may be either postmenopausal, premenopausal, or perimenopausal. a. Postmenopausal status is defined by: i. Age ≥60. ii. Age \<60 and amenorrhea for...
- ECOG performance status of 0 or 1.
- Patient has adequate bone marrow and organ function, as defined by the following laboratory values:
- Absolute neutrophil count (ANC) \>1.0 x 109/L.
- Platelets \>100 x 109/L.
- Hemoglobin \> 8.0 g/dL.
- Potassium, sodium, calcium, and magnesium CTCAE v5.0 grade \<1.
- Cockcroft-Gault based creatinine clearance \>50 mL/min.
- ALT and AST \<3 x ULN and total serum bilirubin \<1.5 x ULN.
- Hypercholesterolemia and hypertriglyceridemia CTCAE v5.0 grade \<1. Exclusion Criteria for Treatment:
- Any concurrent severe and uncontrolled medical condition that would, in the sponsor-investigator's opinion, cause unacceptable safety risks or compromise compliance with the protocol including but not limited to:
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (uncontrolled Crohn's disease or ulcerative colitis, uncontrolled chronic nausea, vomiting...
- Females who are pregnant or breastfeeding.
- Moderate to severe liver impairment (Child-Pugh Class B and C).
- Hypercholesterolemia or hypertriglyceridemia \> CTCAE v5.0 grade 1.
- Participants who are currently or are planning lactation during elacestrant treatment. Lactation during and at least one week following the last dose of elacestrant is not allowed
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- The Bronx, New York, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; The Bronx, New York, United States; Pittsburgh, Pennsylvania, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.