Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palazestrant, Letrozole-matching placebo, Ribociclib, Letrozole.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Belgium, Canada +17
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)
Overview
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
Detailed description
This is an international, multicenter, randomized, double-blind, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the efficacy and safety of palazestrant in combination with ribociclib +letrozole -matching placebo (Arm A: investigational arm) with letrozole in combination with ribociclib + palazestrant-matching placebo (Arm B: control arm).
This trial is seeking adult participants with ER+, HER2- advanced breast cancer who have not received prior systemic anti-cancer treatment for advanced disease. Approximately 1,000 participants will be randomized in a 1:1 ratio to one of the two study arms.
Interventions
- Drug Palazestrant
Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle. - Drug Letrozole-matching placebo
Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle - Drug Ribociclib
Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle. - Drug Letrozole
Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle - Drug Palazestrant matching-placebo
Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)]
Secondary outcome measures (11)
- Overall Survival (OS) [Time frame: From Date of Randomization until Death Due to Any Cause (estimated as up to 5.5 years)]
- Progression Free Survival (PFS) [Time frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)]
- Overall response Rate (ORR) [Time frame: From Date of Randomization until Tumor Response (estimated as up to 3.5 years)]
- Duration of Response (DOR) [Time frame: From Date of Tumor Response (CR or PR) until Disease Progression (estimated as up to 3.5 years)]
- Clinical Benefit Rate (CBR) [Time frame: Proportion of subjects achieving CR, PR or SD with duration of at least 24 weeks (estimated as up to 3.5 years)]
- Overall response Rate (ORR) [Time frame: From Date of Randomization until Tumor Response (estimated as up to 3.5 years)]
- Duration of Response (DOR) [Time frame: From Date of Tumor Response (CR or PR) until Disease Progression (estimated as up to 3.5 years)]
- Clinical Benefit Rate (CBR) [Time frame: Proportion of subjects achieving CR, PR or SD with duration of at least 24 weeks (estimated as up to 3.5 years)]
- Safety and tolerability [Time frame: Up to 42 days after end of treatment (estimated as up to 3.5 years)]
- Pharmacokinetics (PK) of palazestrant and ribociclib [Time frame: Every 28 days (estimated as up to 3.5 years)]
- Health-related patient-reported outcomes (PROs) [Time frame: Every 28 days (estimated as up to 3.5 years)]
Eligibility criteria
Inclusion criteria
- Adult female or male participants.
- ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
- Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
- De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)
- 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 (or LHRH) agonist.
Exclusion criteria
- Disease recurrence during adjuvant endocrine therapy
- Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
- Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
- History of allergic reactions to study treatment.
- Any contraindications to letrozole and ribociclib.
- Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 43 centers
- Clinical Trial Site — Hot Springs
- Clinical Trial Site — Beverly Hills
- Clinical Trial Site — La Jolla
- Clinical Trial Site — Los Alamitos
- Clinical Trial Site — San Francisco
- Clinical Trial Site — Santa Barbara
- Clinical Trial Site — Aurora
- Clinical Trial Site — Denver
- … and 35 more centers
Spain · 15 centers
Center list to be confirmed — check the primary protocol.
South Korea · 12 centers
Center list to be confirmed — check the primary protocol.
Italy · 11 centers
Center list to be confirmed — check the primary protocol.
Australia · 8 centers
- Clinical Trial Site — Sydney
- Clinical Trial Site — Waratah
- Clinical Trial Site — South Brisbane
- Clinical Trial Site — Adelaide
- Clinical Trial Site — Clayton
- Clinical Trial Site — Geelong
- Clinical Trial Site — Heidelberg
- Clinical Trial Site — Nedlands
France · 8 centers
- Clinical Trial Site — Pierre-Bénite
- Clinical Trial Site — Brest
- Clinical Trial Site — Plérin
- Clinical Trial Site — Besançon
- Clinical Trial Site — Montpellier
- Clinical Trial Site — Toulouse
- Clinical Trial Site — Bobigny
- Clinical Trial Site — Villejuif
Malaysia · 8 centers
Center list to be confirmed — check the primary protocol.
Poland · 7 centers
Center list to be confirmed — check the primary protocol.
Romania · 6 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 6 centers
Center list to be confirmed — check the primary protocol.
Belgium · 5 centers
- Clinical Trial Site — Brussels
- Clinical Trial Site — Woluwe-Saint-Lambert
- Clinical Trial Site — Kortrijk
- Clinical Trial Site — Liège
- Clinical Trial Site — Charleroi
Czechia · 5 centers
- Clinical Trial Site — Hořovice
- Clinical Trial Site — Liberec
- Clinical Trial Site — Olomouc
- Clinical Trial Site — Prague
- Clinical Trial Site — Zlín
Thailand · 5 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 5 centers
Center list to be confirmed — check the primary protocol.
Greece · 4 centers
- Clinical Trial Site — Pátrai
- Clinical Trial Site — Athens
- Clinical Trial Site — Athens
- Clinical Trial Site — Thessaloniki
Austria · 3 centers
- Clinical Trial Site — Krems
- Clinical Trial Site — Salzburg
- Clinical Trial Site — Linz
Germany · 3 centers
- Clinical Trial Site — Frankfurt
- Clinical Trial Site — Düsseldorf
- Clinical Trial Site — Torgau
Hong Kong · 3 centers
Center list to be confirmed — check the primary protocol.
Hungary · 3 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 3 centers
Center list to be confirmed — check the primary protocol.
Portugal · 3 centers
Center list to be confirmed — check the primary protocol.
Canada · 1 center
- Clinical Trial Site — Toronto
Identifiers
NCT: NCT07085767 · OP-1250-302 · OPERA-02