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Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-02)
EU CTIS ID: 2025-522873-12-00
What this study is testing
To compare PFS, based on a Local Investigator assessment between investigational (palazestrant with ribociclib + letrozole-matching placebo) and control (letrozole with ribociclib + palazestrant-matching placebo) arms.
- 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
- 1. Adult female or male participants.
- 2. ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
- 3. Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
- 4. De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 6. Adequate hematologic, hepatic, and renal functions.
You likely can't join if
- 1. Disease recurrence during adjuvant endocrine therapy
- 2. Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
- 3. Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
- 4. History of allergic reactions to study treatment.
- 5. Any contraindications to letrozole and ribociclib.
- 6. Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
See the full eligibility criteria
- 1. Adult female or male participants.
- 2. ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
- 3. Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
- 4. De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 6. Adequate hematologic, hepatic, and renal functions.
- 7. Female participants can be pre-, peri- or postmenopausal.
- 8. Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
- 1. Disease recurrence during adjuvant endocrine therapy
- 2. Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
- 3. Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
- 4. History of allergic reactions to study treatment.
- 5. Any contraindications to letrozole and ribociclib.
- 6. Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Thailand
- Canada
- Korea, Republic of
- Taiwan
- Mexico
- Argentina
- United States
- Chile
- Malaysia
- United Kingdom
- Hong Kong
- Philippines
- Australia
- Israel
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 Brazil; Thailand; Canada; Korea, Republic of; Taiwan; Mexico and 9 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.