OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Launched by OLEMA PHARMACEUTICALS, INC. · Aug 29, 2023
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called palazestrant (also known as OP-1250) to see if it is safer and more effective than current standard treatments for people with advanced breast cancer that is hormone receptor-positive (ER+) and HER2-negative. The trial is specifically looking at patients who have already received one type of hormone therapy along with another medication called a CDK4/6 inhibitor but whose cancer has continued to progress. Both men and women aged between 65 and 74 years who meet certain health criteria may be eligible to participate.
To be eligible, participants should have advanced breast cancer that cannot be cured, and they must have measurable disease. They should also have been on a hormone therapy for at least six months before joining the trial. Participants can expect to receive either palazestrant or standard treatment options like fulvestrant or an aromatase inhibitor, and they will be monitored closely for their health and any side effects. It’s important to note that individuals with certain medical conditions or who have received specific previous treatments may not qualify for this trial.
Gender
ALL
Eligibility criteria
- Key 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 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 is allowed. Duration of the most recent prior ET must be at least 6 months.
- • 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.
- Key exclusion criteria:
- • Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.
- • Previously received chemotherapy in the advanced/metastatic setting.
- • Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.
- • History of allergic reactions to study treatment.
- • 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, gastrointestinal disorders that could affect absorption of study treatment.
About Olema Pharmaceuticals, Inc.
Olemma Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery and development of innovative therapies for patients with serious medical conditions. With a commitment to advancing healthcare through cutting-edge research, Olemma harnesses the power of scientific expertise and a robust pipeline to address unmet medical needs. The company collaborates with leading researchers and institutions to drive clinical trials aimed at delivering safe and effective treatment options, ultimately enhancing the quality of life for patients. Olemma's dedication to excellence and patient-centric approach positions it as a key player in the pharmaceutical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Dallas, Texas, United States
Houston, Texas, United States
New York, New York, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Atlanta, Georgia, United States
Aurora, Colorado, United States
Portland, Oregon, United States
Margate, Florida, United States
Port Jefferson Station, New York, United States
Tucson, Arizona, United States
Debrecen, , Hungary
León, , Spain
Lleida, , Spain
Santiago De Compostela, , Spain
Los Angeles, California, United States
Nashville, Tennessee, United States
La Jolla, California, United States
Suwon Si, Gyeonggi Do, Korea, Republic Of
Taipei, , Taiwan
Calgary, Alberta, Canada
Pavia, , Italy
Seoul, , Korea, Republic Of
Taipei City, , Taiwan
Clayton, Victoria, Australia
Plantation, Florida, United States
Belo Horizonte, Minas Gerais, Brazil
Adelaide, South Australia, Australia
Taichung, , Taiwan
Suwon, , Korea, Republic Of
Vratsa, , Bulgaria
Westmead, New South Wales, Australia
Kuching, Sarawak, Malaysia
Valencia, , Spain
Grand Junction, Colorado, United States
Ballarat Central, Victoria, Australia
Shepparton, Victoria, Australia
Nedlands, Western Australia, Australia
Porto Alegre, Rio Grande Do Sul, Brazil
Gosford, New South Wales, Australia
Kowloon, , Hong Kong
Fountain Valley, California, United States
Farmington, New Mexico, United States
Central, , Hong Kong
Petaling Jaya, Selangor, Malaysia
Kaohsiung, , Taiwan
Spokane, Washington, United States
George Town, Penang, Malaysia
Ipoh, Perak, Malaysia
Kuala Lumpur, Wp, Malaysia
Toledo, Ohio, United States
Putrajaya, Putramya, Malaysia
Orlando, Florida, United States
Busan, , Korea, Republic Of
Changhua, , Taiwan
Tainan City, , Taiwan
Taichung, , Taiwan
Kota Bharu, Kelantan, Malaysia
Bangkok, , Thailand
Samut Sakhon, , Thailand
Danbury, Connecticut, United States
Urbana, Illinois, United States
Songkhla, , Thailand
Buenos Aires, , Argentina
Seoul, , Korea, Republic Of
Rosario, Santa Fe, Argentina
La Rioja, , Argentina
Charleroi, Hainaut, Belgium
Leuven, Vlaams Brabant, Belgium
Matosinhos, Porto, Portugal
Lisboa, , Portugal
Porto, , Portugal
Chiang Mai, , Thailand
Hong Kong, , Hong Kong
Meldola, Emilia Romagna, Italy
Denver, Colorado, United States
Golden, Colorado, United States
Saint Louis Park, Minnesota, United States
Edegem, Antwerpen, Belgium
Hradec Králové, Královéhradecký Kraj, Czechia
Nový Jičín, Moravskoslezský Kraj, Czechia
Hong Kong, , Hong Kong
Reggio Emilia, Emilia Romagna, Italy
Sungai Petani, Kedah, Malaysia
Oaxaca, , Mexico
łódź, Lódzkie, Poland
Rzeszów, Podkarpackie, Poland
Skórzewo, Wielkopolskie, Poland
Aurora, Colorado, United States
Jacksonville, Florida, United States
Tamarac, Florida, United States
Atlanta, Georgia, United States
San Salvador De Jujuy, Jujuy, Argentina
Viedma, Río Negro, Argentina
Córdoba, , Argentina
Woluwe Saint Lambert, Brussels, Belgium
Karlsruhe, Baden Württemberg, Germany
Avellino, Campania, Italy
Rozzano, Lombardia, Italy
Otwock, Mazowieckie, Poland
Coimbra, , Portugal
Lisboa, , Portugal
Whittier, California, United States
Plantation, Florida, United States
Chicago, Illinois, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Dayton, Ohio, United States
Dallas, Texas, United States
San Miguel De Tucumán, Tucumán, Argentina
Salvador, Bahia, Brazil
Itajaí, Santa Catarina, Brazil
Sorocaba, São Paulo, Brazil
Rio De Janeiro, , Brazil
Panagyurishte, Pazardzhik, Bulgaria
Sofia, Sofia Grad, Bulgaria
Montréal, Quebec, Canada
Olomouc, Olomoucký Kraj, Czechia
Nantes, Loire Atlantique, France
Compiègne, Oise, France
Clermont Ferrand, Puy De Dôme, France
Le Mans, Sarthe, France
Villejuif, Val De Marne, France
Montpellier, , France
Velbert, Nordrhein Westfalen, Germany
Dresden, Sachsen, Germany
Pécs, Baranya, Hungary
Kecskemét, Bács Kiskun, Hungary
Debrecen, Hajdú Bihar, Hungary
Bologna, Emilia Romagna, Italy
Modena, Emilia Romagna, Italy
Roma, Lazio, Italy
Milano, Lombardia, Italy
Alessandria, Piemonte, Italy
Zapopan, Jalisco, Mexico
Monterrey, , Mexico
Sinaloa, , Mexico
Brzozów, Podkarpackie, Poland
Gdynia, Pomorskie, Poland
Wrocław, , Poland
Mayaguez, , Puerto Rico
Craiova, Dolj, Romania
Pamplona, Navarra, Spain
Alicante, , Spain
Madrid, , Spain
London, , United Kingdom
Newark, Delaware, United States
Jacksonville, Florida, United States
Tamarac, Florida, United States
Baton Rouge, Louisiana, United States
Córdoba, , Argentina
Bourg En Bresse, Ain, France
Besançon, Doubs, France
Krefeld, Nordrhein Westfalen, Germany
Udine, Friuli Venezia Giulia, Italy
Rotterdam, Zuid Holland, Netherlands
Oradea, Bihor, Romania
București, Bucuresti, Romania
Cluj Napoca, Cluj, Romania
Timisoara, Timis, Romania
Brașov, , Romania
Iași, , Romania
Badajoz, , Spain
Chicago, Illinois, United States
Lincoln, Nebraska, United States
Recife, Pernambuco, Brazil
St Louis Park, Minnesota, United States
Viedma, , Argentina
San Miguel De Tucumán, , Argentina
Sorocaba, , Brazil
Hradec Králové, , Czechia
Nový Jičín, , Czechia
Olomouc, , Czechia
Clermont Ferrand, , France
Karlsruhe, , Germany
Kecskemét, , Hungary
łódź, , Poland
Patients applied
Trial Officials
Medical Director, MD
Study Director
Olema Pharmaceuticals, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported