Breast CancerPhase 3OPERA-02NCT07085767
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
A Phase 3 study testing Palazestrant, Ribociclib and Letrozole in people with Breast Cancer and Locally Advanced Breast Cancer, run by Olema Pharmaceuticals, Inc. at 200 sites in 23 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Palazestrant, Ribociclib and Letrozole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 200 sitesin 23 countries
- Study dates
- 3 Nov 2025to Jan 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
200 sites in 23 countries. Contact the study team or a site near you to ask about taking part.
200 sites in 23 countries
United States62 sites, 61 recruiting
- Withdrawn
Clinical Trial Site
Ames, Iowa, 50010
- Recruiting
Clinical Trial Site
Ann Arbor, Michigan, 48109
- Recruiting
Clinical Trial Site
Annapolis, Maryland, 21401
- Recruiting
Clinical Trial Site
Aurora, Colorado, 80045
- Recruiting
Clinical Trial Site
Baltimore, Maryland, 21201
- Recruiting
Clinical Trial Site
Baltimore, Maryland, 21205
- Recruiting
Clinical Trial Site
Bartlett, Tennessee, 38133
- Recruiting
Clinical Trial Site
Beverly Hills, California, 90211
- Recruiting
Clinical Trial Site
Burlington, Massachusetts, 01805
- Recruiting
Clinical Trial Site
Catonsville, Maryland, 21228
- Recruiting
Clinical Trial Site
Charlotte, North Carolina, 28204
- Recruiting
Clinical Trial Site
Cincinnati, Ohio, 45245
- Recruiting
Clinical Trial Site
Columbus, Ohio, 43212
- Recruiting
Clinical Trial Site
Columbus, Ohio, 43219
- Recruiting
Clinical Trial Site
Dallas, Texas, 75235
- Recruiting
Clinical Trial Site
Dallas, Texas, 75390
- Recruiting
Clinical Trial Site
Denton, Texas, 76201
- Recruiting
Clinical Trial Site
Denver, Colorado, 80220
- Recruiting
Clinical Trial Site
Durham, North Carolina, 27710
- Recruiting
Clinical Trial Site
El Paso, Texas, 79902
- Recruiting
Clinical Trial Site
Fort Belvoir, Virginia, 22060
- Recruiting
Clinical Trial Site
Honolulu, Hawaii, 96813
- Recruiting
Clinical Trial Site
Horsham, Pennsylvania, 19044
- Recruiting
Clinical Trial Site
Hot Springs, Arkansas, 71913
- Recruiting
Clinical Trial Site
Houston, Texas, 77024
- Recruiting
Clinical Trial Site
Jackson, Mississippi, 39216
- Recruiting
Clinical Trial Site
Kansas City, Missouri, 64132
- Recruiting
Clinical Trial Site
Knoxville, Tennessee, 37909
- Recruiting
Clinical Trial Site
La Jolla, California, 92093
- Recruiting
Clinical Trial Site
Lebanon, New Hampshire, 03756
- Recruiting
Clinical Trial Site
Los Alamitos, California, 90720
- Recruiting
Clinical Trial Site
Marietta, Georgia, 30060
- Recruiting
Clinical Trial Site
Midlothian, Virginia, 23114
- Recruiting
Clinical Trial Site
Milwaukee, Wisconsin, 52336
- Recruiting
Clinical Trial Site
Minneapolis, Minnesota, 55404
- Recruiting
Clinical Trial Site
Mount Juliet, Tennessee, 37122
- Recruiting
Clinical Trial Site
Nashville, Tennessee, 37232
- Recruiting
Clinical Trial Site
New Haven, Connecticut, 06511
- Recruiting
Clinical Trial Site
New York, New York, 10029
- Recruiting
Clinical Trial Site
New York, New York, 10032
- Recruiting
Clinical Trial Site
Norfolk, Virginia, 23502
- Recruiting
Clinical Trial Site
Oakland, California, 94611
- Recruiting
Clinical Trial Site
Olympia, Washington, 98502
- Recruiting
Clinical Trial Site
Peoria, Illinois, 61615
- Recruiting
Clinical Trial Site
Portland, Oregon, 97239
- Recruiting
Clinical Trial Site
Roseville, California, 95661
- Recruiting
Clinical Trial Site
Salt Lake City, Utah, 84106
- Recruiting
Clinical Trial Site
San Antonio, Texas, 78229
- Recruiting
Clinical Trial Site
San Francisco, California, 94115
- Recruiting
Clinical Trial Site
San Francisco, California, 94158
- Recruiting
Clinical Trial Site
Santa Barbara, California, 93105
- Recruiting
Clinical Trial Site
Santa Clara, California, 95051
- Recruiting
Clinical Trial Site
Santa Fe, New Mexico, 87505
- Recruiting
Clinical Trial Site
Sayre, Pennsylvania, 18840
- Recruiting
Clinical Trial Site
Scarborough, Maine, 04074
- Recruiting
Clinical Trial Site
Seattle, Washington, 98109
- Recruiting
Clinical Trial Site
Tampa, Florida, 33612
- Recruiting
Clinical Trial Site
Tennessee City, Tennessee, 37203
- Recruiting
Clinical Trial Site
Urbana, Illinois, 61801
- Recruiting
Clinical Trial Site
Vallejo, California, 94589
- Recruiting
Clinical Trial Site
Vancouver, Washington, 98684
- Recruiting
Clinical Trial Site
Walnut Creek, California, 94596
Spain15 sites, 15 recruiting
- Recruiting
Clinical Trial Site
Alicante, Alicante, 3010
- Recruiting
Clinical Trial Site
Barcelona, Barcelona, 08028
- Recruiting
Clinical Trial Site
Barcelona, Barcelona, 08035
- Recruiting
Clinical Trial Site
Barcelona, Barcelona, 08036
- Recruiting
Clinical Trial Site
Granada, Granada, 18012
- Recruiting
Clinical Trial Site
León, León, 24071
- Recruiting
Clinical Trial Site
Lleida, Lleida, 25198
- Recruiting
Clinical Trial Site
Madrid, Madrid, 28007
- Recruiting
Clinical Trial Site
Madrid, Madrid, 28040
- Recruiting
Clinical Trial Site
Madrid, Madrid, 28046
- Recruiting
Clinical Trial Site
Madrid, Madrid, 28050
- Recruiting
Clinical Trial Site
Murcia, Murcia, 30120
- Recruiting
Clinical Trial Site
Seville, Sevilla, 41009
- Recruiting
Clinical Trial Site
Valencia, Valencia, 46010
- Recruiting
Clinical Trial Site
Zaragoza, Zaragoza, 50009
Italy12 sites, 12 recruiting
- Recruiting
Clinical Trial Site
Aviano, Friuli Venezia Giulia, 33081
- Recruiting
Clinical Trial Site
Bergamo, Lombardy, 24127
- Recruiting
Clinical Trial Site
Bologna, Emilia-Romagna, 40138
- Recruiting
Clinical Trial Site
Genoa, Liguria, 16132
- Recruiting
Clinical Trial Site
Milan, Lombardy, 20141
- Recruiting
Clinical Trial Site
Milan, Milano, 20132
- Recruiting
Clinical Trial Site
Milan, Varese, 21100
- Recruiting
Clinical Trial Site
Monza, Lombardy, 20900
- Recruiting
Clinical Trial Site
Naples, Campania, 80131
- Recruiting
Clinical Trial Site
Pisa, Tuscany, 56126
- Recruiting
Clinical Trial Site
Prato, Tuscany, 59100
- Recruiting
Clinical Trial Site
Rome, Lazio, 00168
South Korea12 sites, 12 recruiting
- Recruiting
Clinical Trial Site
Busan, Busan Metropolitan City, 49201
- Recruiting
Clinical Trial Site
Daegu, Daegu Metropolitan City, 41404
- Recruiting
Clinical Trial Site
Goyang-si, Gyeonggi-do, 10408
- Recruiting
Clinical Trial Site
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Clinical Trial Site
Seoul, Seoul, 02841
- Recruiting
Clinical Trial Site 1
Seoul, Seoul, 03080
- Recruiting
Clinical Trial Site 2
Seoul, Seoul, 03080
- Recruiting
Clinical Trial Site
Seoul, Seoul, 03722
- Recruiting
Clinical Trial Site
Seoul, Seoul Special City, 05505
- Recruiting
Clinical Trial Site
Seoul, Seoul Special City, 08308
- Recruiting
Clinical Trial Site
Suwon, Gyeonggi-do, 16247
- Recruiting
Clinical Trial Site
Yongin-si, Gyeonggi-do, 16499
France9 sites, 9 recruiting
- Recruiting
Clinical Trial Site
Besançon, Doubs, 25000
- Recruiting
Clinical Trial Site
Bobigny, 93000
- Recruiting
Clinical Trial Site
Brest, Brittany Region, 29609
- Recruiting
Clinical Trial Site
Marseille, Provence-Alpes-Côte d'Azur Region, 13273
- Recruiting
Clinical Trial Site
Montpellier, Hérault, 34070
- Recruiting
Clinical Trial Site
Pierre-Bénite, Auvergne-Rhône-Alpes, 69310
- Recruiting
Clinical Trial Site
Plérin, Brittany Region, 22190
- Recruiting
Clinical Trial Site
Toulouse, Occitanie, 31059
- Recruiting
Clinical Trial Site
Villejuif, Île-de-France Region, 94805
Poland9 sites, 9 recruiting
- Recruiting
Clinical Trial Site
Brzozów, Woj Podkarpackie, 36-200
- Recruiting
Clinical Trial Site
Gdansk, Pomeranian Voivodeship, 80-952
- Recruiting
Clinical Trial Site
Krakow, Lesser Poland Voivodeship, 31-826
- Recruiting
Clinical Trial Site
Lodz, Łódź Voivodeship, 90-302
- Recruiting
Clinical Trial Site
Otwock, Mazowieckir, 05-400
- Recruiting
Clinical Trial Site
Rzeszów, Podkarpackie Voivodeship, 35-055
- Recruiting
Clinical Trial Site
Rzeszów, Podkarpackie Voivodeship, 35-922
- Recruiting
Clinical Trial Site
Warsaw, Masovian Voivodeship, 03-411
- Recruiting
Clinical Trial Site
Wroclaw, Lower Silesian Voivodeship, 53-413
Australia8 sites, 7 recruiting
- Recruiting
Clinical Trial Site
Adelaide, South Australia, 5000
- Terminated
Clinical Trial Site
Clayton, Victoria, 3168
- Recruiting
Clinical Trial Site
Geelong, Victoria, 3220
- Recruiting
Clinical Trial Site
Heidelberg, Victoria, 03084
- Recruiting
Clinical Trial Site
Nedlands, Western Australia, 6009
- Recruiting
Clinical Trial Site
South Brisbane, Queensland, 4101
- Recruiting
Clinical Trial Site
Sydney, New South Wales, 2109
- Recruiting
Clinical Trial Site
Waratah, New South Wales, 2298
Malaysia8 sites, 8 recruiting
- Recruiting
Clinical Trial Site
George Town, Pulau Pinang, 10450
- Recruiting
Clinical Trial Site
Ipoh, Ipoh Perak, 30450
- Recruiting
Clinical Trial Site
Kota Kinabalu, Sabah, 88996
- Recruiting
Clinical Trial Site
Kuala Lumpur, Kuala Lumpur, 50586
- Recruiting
Clinical Trial Site
Kuala Lumpur, Kuala Lumpur, 59100
- Recruiting
Clinical Trial Site
Kuching, Sarawak, 93586
- Recruiting
Clinical Trial Site
Petaling Jaya, Selangor, 46050
- Recruiting
Clinical Trial Site
Putrajaya, Wilayah PE, 62250
Romania6 sites, 6 recruiting
- Recruiting
Clinical Trial Site
Bucharest, Bucharest, 11171
- Recruiting
Clinical Trial Site
Cluj-Napoca, Cluj, 400641
- Recruiting
Clinical Trial Site
Craiova, Dolj, 200542
- Recruiting
Clinical Trial Site
Iași, Iaşi, 700106
- Recruiting
Clinical Trial Site
Ovidiu, Constanța County, 905900
- Recruiting
Clinical Trial Site
Timișoara, Timiș County, 300239
Taiwan6 sites, 6 recruiting
- Recruiting
Clinical Trial Site
Chang-hua, Chang Hua, 50006
- Recruiting
Clinical Trial Site
Kaohsiung City, Sanmin, 80756
- Recruiting
Clinical Trial Site
Taipei, Special Municipality, 11217
- Recruiting
Clinical Trial Site
Taipei, Special Municipality, 11490
- Recruiting
Clinical Trial Site
Taipei, Taipei City, 100
- Recruiting
Clinical Trial Site
Taipei, Taipei City, 10449
United Kingdom6 sites, 6 recruiting
- Recruiting
Clinical Trial Site
Brighton, England, BN2 5BE
- Recruiting
Clinical Trial Site
Cardiff, Wales, CF14 2TL
- Recruiting
Clinical Trial Site
Guildford, Surrey, GU2 7XX
- Recruiting
Clinical Trial Site
London, England, WC1E 6AG
- Recruiting
Clinical Trial Site
London, Greater London, EC1M 6BQ
- Recruiting
Clinical Trial Site
Taunton, Somerset, TA1 5DA
Belgium5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Brussels, Brussels Capital, 1090
- Recruiting
Clinical Trial Site
Charleroi, Wallonia, 6060
- Recruiting
Clinical Trial Site
Kortrijk, Flanders, 8500
- Recruiting
Clinical Trial Site
Liège, Liège Province, 4000
- Recruiting
Clinical Trial Site
Woluwe-Saint-Lambert, Brussels Capital, 1200
Czechia5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Hořovice, Central Bohemia, 26831
- Recruiting
Clinical Trial Site
Liberec, Liberec Region, 46001
- Recruiting
Clinical Trial Site
Olomouc, Olomouc Region, 77900
- Recruiting
Clinical Trial Site
Prague, Prague, 150 06
- Recruiting
Clinical Trial Site
Zlín, Zlín, 762 75
Thailand5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Ban Phaeo, Changwat Samut Sakhon, 74120
- Recruiting
Clinical Trial Site
Bangkok, Bangkok, 10700
- Recruiting
Clinical Trial Site
Chiang Mai, Chiang Mai, 50200
- Recruiting
Clinical Trial Site
Dusit, Bangkok, 10300
- Recruiting
Clinical Trial Site
Hat Yai, Changwat Songkhla, 90110
Austria4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Krems, Lower Austria, 3500
- Recruiting
Clinical Trial Site
Linz, Upper Austria, 4010
- Recruiting
Clinical Trial Site
Salzburg, State of Salzburg, 5020
- Recruiting
Clinical Trial Site
Wels, Upper Austria, 4600
Germany4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Düsseldorf, North Rhine-Westphalia, 40235
- Recruiting
Clinical Trial Site
Frankfurt, Hassen, 60431
- Recruiting
Clinical Trial Site
Torgau, Saxony, 04860
- Recruiting
Clinical Trial Site
Witten, North Rhine-Westphalia, 58452
Greece4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Athens, Attica, 11528
- Recruiting
Clinical Trial Site
Athens, Pireas, 18547
- Recruiting
Clinical Trial Site
Pátrai, Achaia, 26504
- Recruiting
Clinical Trial Site
Thessaloniki, Thessaloniki, 57001
Hungary4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Debrecen, Hajdú-Bihar, 4032
- Recruiting
Clinical Trial Site
Győr, Győr-Moson-Sopron, 9024
- Recruiting
Clinical Trial Site
Kecskemét, Bács-Kiskun county, 6000
- Recruiting
Clinical Trial Site
Szekszárd, Tolna County, 7100
Israel4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Ashdod, Southern District, 7747629
- Recruiting
Clinical Trial Site
Jerusalem, Jerusalem, 91999
- Recruiting
Clinical Trial Site
Kfar Saba, Central District, 44281
- Recruiting
Clinical Trial Site
Petah Tikva, Central District, 4941492
Portugal4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Coimbra, Coimbra District, 3000-459
- Recruiting
Clinical Trial Site
Lisbon, Lisbon District, 1099-023
- Recruiting
Clinical Trial Site
Porto, Porto District, 4200-072
- Recruiting
Clinical Trial Site
Porto, Porto District, 4464-513
Hong Kong3 sites, 3 recruiting
- Recruiting
Clinical Trial Site
Hong Kong, Hong Kong, 999077
- Recruiting
Clinical Trial Site
Hong Kong, Kowloon, 999077
- Recruiting
Clinical Trial Site
Hong Kong, Pok Fu Lam, 999077
Netherlands3 sites, 3 recruiting
- Recruiting
Clinical Trial Site
Amsterdam, North Holland, 1081 HV
- Recruiting
Clinical Trial Site
Apeldoorn, Gelderland, 7334 DZ
- Recruiting
Clinical Trial Site
Maastricht, Limberg, 6202 AZ
Canada2 sites, 2 recruiting
- Recruiting
Clinical Trial Site
Greenfield Park, Quebec, J4V 2H1
- Recruiting
Clinical Trial Site
Toronto, Ontario, M2J 1V1
About this study
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)
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.
Read the 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.
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
- Being tested
- Palazestrant, Letrozole-matching placebo, Ribociclib, Letrozole, Palazestrant matching-placebo
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalazestrantDrug
Also called OP-1250
Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.
Letrozole-matching placeboDrug
Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle
RibociclibDrug
Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.
LetrozoleDrug
Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle
Palazestrant matching-placeboDrug
Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle
| Study group | Role | What they receive |
|---|---|---|
| Palazestrant | Experimental | Participants will receive palazestrant, ribociclib and letrozole-matching placebo Receives: Drug: Palazestrant; Drug: Letrozole-matching placebo; Drug: Ribociclib |
| Letrozole | Active comparator | Participants will receive letrozole, ribociclib and palazestrant-matching placebo Receives: Drug: Ribociclib; Drug: Letrozole; Drug: Palazestrant matching-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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.
Measured: From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)
Secondary outcomes (11)
Overall Survival (OS)
To compare OS between investigational and control arms.
Measured: From Date of Randomization until Death Due to Any Cause (estimated as up to 5.5 years)
Progression Free Survival (PFS)
To evaluate PFS based on Blinded Independent Review Committee (BIRC) assessment
Measured: From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 3.5 years)
Overall response Rate (ORR)
To evaluate ORR based on Blinded Independent Review Committee (BIRC) assessment
Measured: From Date of Randomization until Tumor Response (estimated as up to 3.5 years)
Duration of Response (DOR)
To evaluate DOR based on Blinded Independent Review Committee (BIRC) assessment
Measured: From Date of Tumor Response (CR or PR) until Disease Progression (estimated as up to 3.5 years)
Clinical Benefit Rate (CBR)
To evaluate CBR based on Blinded Independent Review Committee (BIRC) assessment
Measured: 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)
To evaluate ORR based on local investigator assessment
Measured: From Date of Randomization until Tumor Response (estimated as up to 3.5 years)
Duration of Response (DOR)
To evaluate DOR based on local investigator assessment
Measured: From Date of Tumor Response (CR or PR) until Disease Progression (estimated as up to 3.5 years)
Clinical Benefit Rate (CBR)
To evaluate CBR based on local investigator assessment
Measured: 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
To evaluate safety and tolerability assessed by AEs, SAEs, dose modifications, clinical laboratory parameters, ECGs, performance status and vital sign measurements
Measured: Up to 42 days after end of treatment (estimated as up to 3.5 years)
Pharmacokinetics (PK) of palazestrant and ribociclib
To evaluate plasma levels of palazestrant and ribociclib to establish pharmacokinetic (PK) parameters
Measured: Every 28 days (estimated as up to 3.5 years)
Health-related patient-reported outcomes (PROs)
To evaluate the change from baseline in health-related PROs assessed using standardized instruments that are widely used in (breast) cancer clinical trials
Measured: Every 28 days (estimated as up to 3.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start3 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olema Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Olema Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085767
- Sponsor's protocol ID
- OP-1250-302
- Other IDs
- OPERA-02
- Acronym
- OPERA-02
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No