Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Brea… (NCT05618613) | Clinical Trial Compass
TerminatedPhase 1/2
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
Stopped: Sponsor decision to discontinue onapristone development.
United States4 participantsStarted 2022-12-02
Plain-language summary
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Women or men aged ≥18 years, at the time of informed consent signature. Note: Pre- and peri-menopausal women must receive goserelin for at least one month prior to initiating trial therapy, during the trial, and for at least one month after end of trial therapy. Men must receive triptorelin for at least one month prior to initiating trial therapy, during the trial and for at least one month after end of trial therapy.
. Histopathologically or cytologically confirmed ER+, PgR+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al, 2020). Note: In the context of this trial, ER and PgR status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry.
. At least one measurable lesion as per RECIST version 1.1. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and has discontinued the use of corticosteroids for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Dose-Limiting Toxicities (DLTs) During First Cycle
Timeframe: First 28 days (Cycle 1)
2
Objective Response Rate (ORR)
Timeframe: Assessed every 8 weeks until disease progression, up to approximately 6 months
. Prior therapy with an aromatase inhibitor or fulvestrant + a CDK4/6 inhibitor in the metastatic setting or in the adjuvant setting if within 12 months of last dose of adjuvant therapy. Note: Prior therapy with everolimus is allowed.
. 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) ≥1.5 × 109/L,
. Platelets ≥100 × 109/L,
Exclusion criteria
. Active or newly diagnosed CNS metastases, including meningeal carcinomatosis.
. Breast cancer treatment-naïve patients in the metastatic setting.
. Prior therapy with elacestrant, onapristone, or chemotherapy in the metastatic setting.
. Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy.
. Uncontrolled significant active infections.
. Patients with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection must have undetectable viral load during screening.
. Patients known to be HIV+ are allowed as long as they have undetectable viral load at baseline.
. Major surgery within 4 weeks before starting trial therapy.