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STUDY OF OP-1250 ADMINSTERED AS MONOTHERAPY AND COMPARED TO STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2– ADVANCED OR METASTATIC BREAST CANCER
EU CTIS ID: 2023-505871-63-00
What this study is testing
1. To evaluate the safety of OP-1250 at the dose levels of 90 and 120 mg 2. To compare PFS, based on a BIRC assessment, between arms of OP-1250 at the selected dose and SOC treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Adult female or male participants. • ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy. • Evaluable disease (measurable disease or bone-only disease). • Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy will be allowed. • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. • Adequate hematologic, hepatic, and renal functions. • Female participants can be pre-, peri- or postmenopausal. • Male and pre- or peri-menopausal female participants must be willing to take a GnRH (LHRH) agonist.
You likely can't join if
- • Symptomatic visceral disease, imminent organ failure, or any disease burden that makes the participant ineligible for endocrine therapy. • Have received prior chemotherapy (including an antibody-drug conjugate) in the advanced/metastatic setting. • Any contraindications to the selected standard of care endocrine therapy in the local prescribing information. • Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment • Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, or gastrointestinal disorders that could aff+F120ect absorption of study treatment, and others
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Korea, Republic of
- Thailand
- Australia
- Taiwan
- Argentina
- Malaysia
- Hong Kong
- Mexico
- United States
- Brazil
- Singapore
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Korea, Republic of; Thailand; Australia; Taiwan; Argentina and 7 more location(s). 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 EU CTIS; the study team decides eligibility.