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Compares treatment options for Estrogen-receptor-positive Breast Cancer
Official title Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06062498
What this study is testing
What is elacestrant, palbociclib, abemaciclib, ribociclib?
elacestrant, palbociclib, abemaciclib, ribociclib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for estrogen-receptor-positive 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
- Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype.
- Phase 2: a mid-size study of how well it works
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
- All Arms:
- Patients must have histologically or cytologically confirmed ER-positive and HER2- negative breast cancer as per the American Society of Clinical...
- Patients must have a confirmed ESR1 mutation. Note: This information will be drawn from patients' treatment charts. Mutational analysis will be done...
- Patients must have at least one measurable lesion (as per RECIST v1.1) lesion anywhere in the body or a mainly lytic metastatic bone lesion. Note...
- Patients must have received at least 2 prior endocrine therapies, including a CDK4/6 inhibitor in the metastatic disease setting.
You likely can't join if
- All Arms:
- Patients who have received prior elacestrant.
- Patients who have had chemotherapy or radiotherapy ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration.
- Patients who have taken steroid therapy or any other immunosuppressive therapy within 7 days of first dose prior to trial treatment.
- Patients with brain metastases. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and...
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 3) with the exception...
See the full eligibility criteria
Who can join
- All Arms:
- Patients must have histologically or cytologically confirmed ER-positive and HER2- negative breast cancer as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines...
- Patients must have a confirmed ESR1 mutation. Note: This information will be drawn from patients' treatment charts. Mutational analysis will be done as standard of care; there is no research-related mutational testing...
- Patients must have at least one measurable lesion (as per RECIST v1.1) lesion anywhere in the body or a mainly lytic metastatic bone lesion. Note: Lytic bone lesions with identifiable soft tissue components that can be...
- Patients must have received at least 2 prior endocrine therapies, including a CDK4/6 inhibitor in the metastatic disease setting.
- Patients must be age ≥ 18 years. Patients of childbearing potential (POCBP) may be premenopausal, postmenopausal, or perimenopausal.
- Potential POCBP who may be menopausal and are \ 40 mIU/mL to confirm menopause.
- Patients must exhibit an ECOG performance status of 0 or 1.
- Patients must have adequate organ and bone marrow function as defined below: Leukocytes (WBC) ≥ 3,000/mcL Absolute neutrophil count (ANC) ≥ 1,500/mcL Hemoglobin (Hgb) ≥ 80-100 g/dL Platelets (PLT) ≥ 50,000/mcL Total...
- 5 x institutional ULN (liver metastases present) ALT (SGPT) ≤ 3 x institutional ULN
- 5 x institutional ULN (liver metastases present) Cockcroft-Gault based creatinine clearance
- 50 mL/min Note:
- Creatinine clearance (DMAB) = ([140-age in years] × weight in kg)/ ([serum creatinine in mg/dL] × 72)
- Creatinine clearance (DFAB) = (0.85 × [140-age in years] × weight in kg)/ ([serum creatinine in mg/dL] × 72) Note: Growth factor/transfusion support to attain these levels is not permitted.
- For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.
- For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) Note: POCBP who are on combination therapy with any study CKD4/6 inhibitor...
- Combination Therapy Arm 2 with Palbociclib, Abemaciclib, or Ribociclib -Patients who have been treated with one or two prior hormonal therapies in the metastatic setting if at least one hormonal therapy was in...
- Patients who are already on or have already been exposed to one or two of the study CDK4/6 inhibitors at registration will be assigned a different study CDK4/6 inhibitor (e.g., if a patient has already been exposed to...
- One-to-one randomization will be done by the QA team once patients have been registered.
What rules you out
- All Arms:
- Patients who have received prior elacestrant.
- Patients who have had chemotherapy or radiotherapy ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration.
- Patients who have taken steroid therapy or any other immunosuppressive therapy within 7 days of first dose prior to trial treatment.
- Patients with brain metastases. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for...
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 3) with the exception of alopecia.
- Patients who are receiving any other investigational agents. For patients who were previously on palbociclib, abemaciclib, or ribociclib, the washout period between stopping that CDK4/6 inhibitor and starting a...
- Patients with advanced, symptomatic visceral spread who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary...
- Patients with documented pneumonitis/interstitial lung disease prior to registration.
- Patients who have received major surgery within 28 days before starting trial therapy.
- Patients who are taking strong or moderate CYP3A4 inducers or strong or moderate CYP3A4 inhibitors. See Section 4.4 for additional incompatibilities.
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant. Note: Refer to exclusion criteria below for eligibility criteria related to study...
- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:
- Hypertension that is not controlled on medication
- Psychiatric illness/social situations that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Patients with refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection or gastric bypass surgery), history of malabsorption syndrome, or any other uncontrolled...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.