Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-01 @ 7:22 PM
Study NCT ID:
NCT07085767
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589651', 'term': 'ribociclib'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From Date of Randomization until Death Due to Any Cause (estimated as up to 5.5 years)', 'description': 'To compare OS between investigational and control arms.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)', 'description': 'To evaluate PFS based on Blinded Independent Review Committee (BIRC) assessment'}, {'measure': 'Overall response Rate (ORR)', 'timeFrame': 'From Date of Randomization until Tumor Response (estimated as up to 3.5 years)', 'description': 'To evaluate ORR based on Blinded Independent Review Committee (BIRC) assessment'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From Date of Tumor Response (CR or PR) until Disease Progression (estimated as up to 3.5 years)', 'description': 'To evaluate DOR based on Blinded Independent Review Committee (BIRC) assessment'}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'Proportion of subjects achieving CR, PR or SD with duration of at least 24 weeks (estimated as up to 3.5 years)', 'description': 'To evaluate CBR based on Blinded Independent Review Committee (BIRC) assessment'}, {'measure': 'Overall response Rate (ORR)', 'timeFrame': 'From Date of Randomization until Tumor Response (estimated as up to 3.5 years)', 'description': 'To evaluate ORR based on local investigator assessment'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From Date of Tumor Response (CR or PR) until Disease Progression (estimated as up to 3.5 years)', 'description': 'To evaluate DOR based on local investigator assessment'}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'Proportion of subjects achieving CR, PR or SD with duration of at least 24 weeks (estimated as up to 3.5 years)', 'description': 'To evaluate CBR based on local investigator assessment'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Up to 42 days after end of treatment (estimated as up to 3.5 years)', 'description': 'To evaluate safety and tolerability assessed by AEs, SAEs, dose modifications, clinical laboratory parameters, ECGs, performance status and vital sign measurements'}, {'measure': 'Pharmacokinetics (PK) of palazestrant and ribociclib', 'timeFrame': 'Every 28 days (estimated as up to 3.5 years)', 'description': 'To evaluate plasma levels of palazestrant and ribociclib to establish pharmacokinetic (PK) parameters'}, {'measure': 'Health-related patient-reported outcomes (PROs)', 'timeFrame': 'Every 28 days (estimated as up to 3.5 years)', 'description': 'To evaluate the change from baseline in health-related PROs assessed using standardized instruments that are widely used in (breast) cancer clinical trials'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized', 'Multicenter', 'Double-Blind', 'Active-Controlled', 'Phase 3', 'Palazestrant', 'Complete Estrogen Receptor Antagonist (CERAN)', 'Selective Estrogen Receptor Degrader (SERD)', 'Ribociclib', 'CDK4/6i', 'Letrozole', 'Aromatase inhibitors', 'Antineoplastic agents'], 'conditions': ['Breast Cancer', 'Locally Advanced Breast Cancer', 'Metastatic Breast Cancer', 'ER Positive Breast Cancer', 'HER2 Negative Breast Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://olema.com/science/publications', 'label': 'Olema Publications'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).\n* De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nExclusion Criteria:\n\n* Disease recurrence during adjuvant endocrine therapy\n* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.\n* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.\n* History of allergic reactions to study treatment.\n* Any contraindications to letrozole and ribociclib.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.'}, 'identificationModule': {'nctId': 'NCT07085767', 'acronym': 'OPERA-02', 'briefTitle': 'Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olema Pharmaceuticals, Inc.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'OP-1250-302'}, 'secondaryIdInfos': [{'id': 'OPERA-02', 'type': 'OTHER', 'domain': 'Olema Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palazestrant', 'description': 'Participants will receive palazestrant, ribociclib and letrozole-matching placebo', 'interventionNames': ['Drug: Palazestrant', 'Drug: Letrozole-matching placebo', 'Drug: Ribociclib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Letrozole', 'description': 'Participants will receive letrozole, ribociclib and palazestrant-matching placebo', 'interventionNames': ['Drug: Ribociclib', 'Drug: Letrozole', 'Drug: Palazestrant matching-placebo']}], 'interventions': [{'name': 'Palazestrant', 'type': 'DRUG', 'otherNames': ['OP-1250'], 'description': 'Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.', 'armGroupLabels': ['Palazestrant']}, {'name': 'Letrozole-matching placebo', 'type': 'DRUG', 'description': 'Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle', 'armGroupLabels': ['Palazestrant']}, {'name': 'Ribociclib', 'type': 'DRUG', 'description': 'Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.', 'armGroupLabels': ['Letrozole', 'Palazestrant']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle', 'armGroupLabels': ['Letrozole']}, {'name': 'Palazestrant matching-placebo', 'type': 'DRUG', 'description': 'Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle', 'armGroupLabels': ['Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50010', 'city': 'Ames', 'state': 'Iowa', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '87505', 'city': 'Santa Fe', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 35.68698, 'lon': -105.9378}}, {'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'zip': '37203', 'city': 'Tennessee City', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 36.09312, 'lon': -87.51474}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '2109', 'city': 'Macquarie University', 'state': 'New South Wales', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Clinical Trial Site'}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'centralContacts': [{'name': 'Olema Pharmaceuticals, Inc.', 'role': 'CONTACT', 'email': 'OPERA-02@olema.com', 'phone': '415-651-7206'}], 'overallOfficials': [{'name': 'Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Olema Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olema Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}