A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Launched by HOFFMANN-LA ROCHE · Sep 26, 2023
Trial Information
Current as of July 28, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called the pionERA study, is researching two different medications, giredestrant and fulvestrant, both used with a type of drug called a CDK4/6 inhibitor, to see which one works better for treating advanced breast cancer that is estrogen receptor-positive (ER+) and HER2-negative. This study is specifically for patients who have already received some hormone treatments but their cancer did not respond well. The trial aims to find out how effective and safe these treatments are.
To be eligible for this trial, participants must have advanced breast cancer that is not curable, with a confirmed ER+ and HER2- status from a recent biopsy. They should also have a specific mutation in their tumor's DNA and must have shown resistance to earlier hormone treatments. People aged 65 to 74, regardless of gender, can participate, and those who are premenopausal will need to agree to receive additional hormone therapy during the trial. Participants can expect regular check-ups and monitoring while receiving one of the study medications, contributing to important research that may help improve treatment options for others in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- • Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
- • Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
- • Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \>/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred \>/=12 months since completion).
- • No prior systemic anti-cancer therapy for advanced disease
- • Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
- • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- • For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment
- Exclusion Criteria:
- • Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
- • Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
- • Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
- • Active cardiac disease or history of cardiac dysfunction
- • Clinically significant history of liver disease
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charleston, South Carolina, United States
Lyon, , France
Sioux Falls, South Dakota, United States
Avignon, , France
Lille, , France
Detroit, Michigan, United States
Edmonton, Alberta, Canada
Oshawa, Ontario, Canada
Regina, Saskatchewan, Canada
Lima, , Peru
Rennes, , France
Toronto, Ontario, Canada
Hong Kong, , Hong Kong
Boston, Massachusetts, United States
Washington, District Of Columbia, United States
Park Ridge, Illinois, United States
Gent, , Belgium
Huelva, , Spain
Christchurch, , New Zealand
Tacoma, Washington, United States
Greenbrae, California, United States
Bruxelles, , Belgium
Leuven, , Belgium
Jau, Sp, Brazil
Mississauga, Ontario, Canada
Hangzhou, , China
Shanghai City, , China
Freiburg, , Germany
Patras, , Greece
Jerusalem, , Israel
Palmerston North, , New Zealand
Szczecin, , Poland
Porto, , Portugal
Singapore, , Singapore
Jaen, , Spain
Valencia, , Spain
Taipei City, , Taiwan
Austin, Texas, United States
Porto Alegre, Rs, Brazil
Caen, , France
Innsbruck, , Austria
Los Angeles, California, United States
Taichung, , Taiwan
Reims Cedex, , France
Lyon, , France
Lexington, Kentucky, United States
Geelong, Victoria, Australia
Warrnambool, Victoria, Australia
Atlanta, Georgia, United States
Erlangen, , Germany
Kingswood, New South Wales, Australia
Thunder Bay, Ontario, Canada
Villejuif, , France
Cincinnati, Ohio, United States
Singapore, , Singapore
Clermont Ferrand, , France
Green Bay, Wisconsin, United States
Sevilla, , Spain
Fairfax, Virginia, United States
Sevilla, , Spain
Valencia, , Spain
Bangkok, , Thailand
Porto Alegre, Rs, Brazil
Louisville, Kentucky, United States
Bangkok, , Thailand
Shanghai, , China
Harbor City, California, United States
Barrie, Ontario, Canada
Springfield, Illinois, United States
Seongnam Si, , Korea, Republic Of
Trois Rivieres, Quebec, Canada
Pune, Maharashtra, India
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bangkok, , Thailand
Besancon, , France
New Delhi, Delhi, India
Tianjin, Tianjin, China
Tampere, , Finland
Beijing, , China
Hong Kong, , Hong Kong
Auburn, California, United States
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Trivandrum, Kerala, India
Jau, Sp, Brazil
Milano, Lombardia, Italy
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Altamonte Springs, Florida, United States
Seoul, , Korea, Republic Of
Washington, District Of Columbia, United States
Heidelberg, , Germany
Koeln, , Germany
Guatemala City, , Guatemala
Hong Kong, , Hong Kong
Macerata, Marche, Italy
Madrid, , Spain
Songkhla, , Thailand
Cordoba, , Argentina
Budapest, , Hungary
Liège, , Belgium
Barretos, Sp, Brazil
Denver, Colorado, United States
Dallas, Texas, United States
Lublin, , Poland
Scarborough, Maine, United States
Saskatoon, Saskatchewan, Canada
Harbin, , China
Caen, , France
Muenchen, , Germany
Aviano (Pn), Friuli Venezia Giulia, Italy
Lisboa, , Portugal
Jerez De La Frontera, Cadiz, Spain
Sevilla, , Spain
Essen, , Germany
La Rioja, , Argentina
Besancon, , France
Homburg/Saar, , Germany
Lima, , Peru
Songkhla, , Thailand
Porto Alegre, Rio Grande Do Sul, Brazil
Coimbra, , Portugal
Lima, , Peru
Sao Paulo, , Brazil
Lima, , Peru
Namur, , Belgium
Lille, , France
Reims Cedex, , France
Erlangen, , Germany
Udine, Friuli Venezia Giulia, Italy
Wien, , Austria
Graz, , Austria
Ulsan, , Korea, Republic Of
Rosario, , Argentina
Sao Paulo, Sp, Brazil
Budapest, , Hungary
Huelva, , Spain
Sevilla, , Spain
Jacksonville, Florida, United States
Napoli, Campania, Italy
Seoul, , Korea, Republic Of
Wilrijk, , Belgium
Athens, , Greece
Linz, , Austria
Ljubljana, , Slovenia
Madrid, , Spain
St Albans, Victoria, Australia
Angers, , France
Lisboa, , Portugal
Hong Kong, , Hong Kong
Lima, , Peru
Santiago, , Chile
Germantown, Tennessee, United States
Littleton, Colorado, United States
Rosario, , Argentina
Fuzhou City, , China
Rozzano, Lombardia, Italy
Jinan, , China
Zhengzhou, , China
Jau, São Paulo, Brazil
Morgantown, West Virginia, United States
Chengdu, , China
Wuhan, , China
Monteria, , Colombia
Deggendorf, , Germany
Homburg/Saar, , Germany
Mönchengladbach, , Germany
Brescia, Lombardia, Italy
Trujillo, , Peru
Warszawa, , Poland
Valencia, , Spain
Iasi, , Romania
Nanning, , China
Thessaloniki, , Greece
Roma, Lazio, Italy
La Rochelle, , France
Buenos Aires, , Argentina
Porto Alegre, Rs, Brazil
Arequipa, , Peru
Pozuelo De Alarcon, Madrid, Spain
Taichung, , Taiwan
Athens, , Greece
Xuzhou, Jiangsu, China
Goiania, Go, Brazil
Port Elizabeth, , South Africa
Sao Paulo, Sp, Brazil
Rennes, , France
Zhejiang, , China
Chongqing, , China
Daegu, , Korea, Republic Of
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Bologna, Emilia Romagna, Italy
Padova, Veneto, Italy
Parma, Emilia Romagna, Italy
Urumqi, , China
Porto Alegre, Rio Grande Do Sul, Brazil
Rozzano, Lombardia, Italy
Seoul, , Korea, Republic Of
Misterbianco (Ct), Sicilia, Italy
Florence, Toscana, Italy
Milwaukee, Wisconsin, United States
San José, , Costa Rica
Steyr, , Austria
Ramat Gan, , Israel
Daphne, Alabama, United States
Gdynia, , Poland
Petah Tikva, , Israel
Jamaica, New York, United States
Changchun City, , China
Trujillo, , Peru
Konin, , Poland
Novara, Piemonte, Italy
Avellino, Campania, Italy
Sippy Downs, Queensland, Australia
Vitoria, Es, Brazil
San José, , Costa Rica
Providence, Rhode Island, United States
Palmerston North, , New Zealand
Craiova, , Romania
Taipei, , Taiwan
El Palmar, Murcia, Spain
Wuhan City, , China
Roma, Lazio, Italy
Kansas City, Missouri, United States
Sacramento, California, United States
Heidelberg, , Germany
Changsha City, , China
Barcelona, , Spain
Mechelen, , Belgium
Frenchs Forest, New South Wales, Australia
Guangzhou City, , China
South Brisbane, Queensland, Australia
Bergamo, Lombardia, Italy
Tel Aviv, , Israel
Jinan City, , China
Frederick, Maryland, United States
Sao Paulo, Sp, Brazil
Meldola, Emilia Romagna, Italy
Saint Petersburg, Florida, United States
Xi'an City, , China
Brescia, Lombardia, Italy
Bucuresti, , Romania
Cape Town, , South Africa
Guatemala, , Guatemala
Szczecin, , Poland
Toulouse, , France
Recife, Pe, Brazil
Taiyuan City, , China
Lancaster, Pennsylvania, United States
Rio De Janeiro, Rj, Brazil
Atlanta, Georgia, United States
Samsun, , Turkey
Vigo, Pontevedra, Spain
Innsbruck, , Austria
Ijui, Rs, Brazil
Porto Alegre, Rs, Brazil
Oaxaca De Juárez, Oaxaca, Mexico
Mexico City, , Mexico
Bamberg, , Germany
Tallahassee, Florida, United States
East Brunswick, New Jersey, United States
Santiago, , Chile
Ciudad De Guatemala, , Guatemala
Gdynia, , Poland
Ankara, , Turkey
Timisoara, , Romania
San Juan, , Puerto Rico
Linz, , Austria
York, Pennsylvania, United States
Pune, Maharashtra, India
Lak Si, , Thailand
La Rochelle, , France
Adelaide, South Australia, Australia
Brindisi, Puglia, Italy
Lisboa, , Portugal
Monterrey, Nuevo Leon, Mexico
Taizhou, , China
Kuopio, , Finland
Rosario, , Argentina
Kingswood, New South Wales, Australia
Vigo, Pontevedra, Spain
Porto Alegre, Rio Grande Do Sul, Brazil
Barcelona, , Spain
Levis, Quebec, Canada
Luoyang, , China
Chicoutimi, Quebec, Canada
Xitun Dist., , Taiwan
West Palm Beach, Florida, United States
Bakirkoy / Istanbul, , Turkey
Taizhou, , China
Philadelphia, Pennsylvania, United States
Düsseldorf, , Germany
Guadalajara, Jalisco, Mexico
Queréaro, Queretaro, Mexico
Santiago, , Chile
Athina, , Greece
Ciudad De Guatemala, , Guatemala
Salcajá, , Guatemala
Hsinchu City, , Taiwan
Annapolis, Maryland, United States
Medford, Oregon, United States
Ciudad Autonoma Buenos Aires, , Argentina
Bensalem, Pennsylvania, United States
Richmond, Virginia, United States
Valledupar, , Colombia
Recoleta, , Argentina
Lima, , Peru
Mersin, , Turkey
Adelaide, South Australia, Australia
Fortaleza, Ce, Brazil
Petah Tikva, , Israel
North Sydney, New South Wales, Australia
Kozhikode, Kerala, India
Jacksonville, Florida, United States
Cerritos, California, United States
Badalona, Barcelona, Spain
Bydgoszcz, , Poland
Gliwice, , Poland
Koszalin, , Poland
Kielce, , Poland
Taipei City, , Taiwan
Fuzhou City, , China
?ód?, , Poland
Pretoria, , South Africa
Wuhan City, , China
Lima, , Peru
Bogota, D.C., , Colombia
Singapore, , Singapore
Sant Andreu De La Barca, Barcelona, Spain
Banglore, Karnataka, India
Kecskemét, , Hungary
Mexico City, , Mexico
Mexico City, Mexico City (Federal District), Mexico
Singapore, , Singapore
Newport Beach, California, United States
Montreal, Quebec, Canada
Tianjin, , China
Thessaloniki, , Greece
Chengdu City, , China
Nairobi, , Kenya
Luoyang City, , China
Miskolc, , Hungary
Xian, Shaanxi, China
Quebec City, Quebec, Canada
Nashville, Tennessee, United States
San José, , Costa Rica
Seoul, , Korea, Republic Of
Mumbai, Maharashtra, India
Rio De Janeiro, , Brazil
Nanning City, , China
Porto Alegre, Rs, Brazil
Aberdeen, South Dakota, United States
Puerto Montt, , Chile
Buenos Aires, , Argentina
Saint Jerome, Quebec, Canada
Ciudad De Guatemala, , Guatemala
Quetzaltenango, , Guatemala
Vila Nova De Gaia, , Portugal
Changchun City, , China
Guadalajara, Jalisco, Mexico
San Juan, , Argentina
Salvador, Ba, Brazil
Santiago, , Chile
Kunming City, , China
San José, , Costa Rica
Torrance, California, United States
San Juan, , Argentina
Montpellier, , France
Salgótarján, , Hungary
Muang Chiang Mai Delivery Branch 3, , Thailand
Kecskemét, , Hungary
Des Moines, Iowa, United States
Lima, , Peru
Lima, , Peru
Siedlce, , Poland
Sao Luis, , Brazil
Lublin, , Poland
Lexington, Kentucky, United States
Fort Myers, Florida, United States
Sao Luis, Ma, Brazil
Cali, , Colombia
Szczecin, , Poland
Singapore, , Singapore
Tampa, Florida, United States
Ciudad De Guatemala, , Guatemala
Santiago De Querétaro, Queretaro, Mexico
Bangkok, , Thailand
Fort Worth, Texas, United States
Thunder Bay, Ontario, Canada
Ciudad De México, Mexico City (Federal District), Mexico
Whangarei, , New Zealand
Providencia, , Chile
Sao Paulo, São Paulo, Brazil
Mexico City, , Mexico
Lima, , Peru
Coimbra, , Portugal
Porto, , Portugal
Macerata, Marche, Italy
Bydgoszcz, , Poland
Vila Nova De Gaia, , Portugal
Jaen, , Spain
Madrid, , Spain
Goiania, Goiás, Brazil
Recife, Pernambuco, Brazil
Athens, , Greece
Misterbianco (Ct), Sicilia, Italy
Padova, Veneto, Italy
Warszawa, , Poland
Pozuelo De Alarcon, Madrid, Spain
Madrid, , Spain
Taipei, , Taiwan
Izmir, , Turkey
Banglore, Karnataka, India
Sihhiye/Ankara, , Turkey
Barretos, São Paulo, Brazil
Milano, Lombardia, Italy
Ciudad Autonoma Buenos Aires, , Argentina
Fortaleza, Ceará, Brazil
Sao Paulo, São Paulo, Brazil
Meldola, Emilia Romagna, Italy
Gliwice, , Poland
Koszalin, , Poland
Muenchen, , Germany
Aviano (Pn), Friuli Venezia Giulia, Italy
Kielce, , Poland
Jerez De La Frontera, Cadiz, Spain
Sao Paulo, São Paulo, Brazil
Vitoria, Espírito Santo, Brazil
Newport Beach, California, United States
Ijui, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Larissa, , Greece
Cluj County, , Romania
Frederick, Maryland, United States
Bologna, Emilia Romagna, Italy
?ód?, , Poland
Koeln, , Germany
Roma, Lazio, Italy
Kadiköy, , Turkey
Jerusalem, , Israel
Miskolc, , Hungary
Lisboa, , Portugal
Tel Aviv, , Israel
Sant Andreu De La Barca, Barcelona, Spain
Pennington, New Jersey, United States
Raleigh, North Carolina, United States
Irving, Texas, United States
Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
North Sydney, New South Wales, Australia
Salvador, Bahia, Brazil
Brasilia, Distrito Federal, Brazil
Sao Luis, Maranhão, Brazil
Montreal, Quebec, Canada
Providencia, , Chile
Guangzhou City, , China
Kuopio, , Finland
Deggendorf, , Germany
Ciudad De Guatemala, , Guatemala
Salgótarján, , Hungary
Udine, Friuli Venezia Giulia, Italy
Brindisi, Puglia, Italy
Whangarei, , New Zealand
Siedlce, , Poland
Cluj Napoca, , Romania
El Palmar (El Palmar), Murcia, Spain
Lak Si, , Thailand
Muang Chiang Mai Delivery Branch 3, , Thailand
Christchurch, , New Zealand
Charleroi, , Belgium
Glendale, California, United States
Providence, Rhode Island, United States
Thane, Maharashtra, India
O'fallon, Missouri, United States
Omaha, Nebraska, United States
Roseville, California, United States
Guatemala, , Guatemala
Adapazar?, , Turkey
Jau, , Brazil
Barretos, , Brazil
Sao Paulo, , Brazil
Goiania, , Brazil
Sao Paulo, , Brazil
Vitoria, , Brazil
Fortaleza, , Brazil
Mexico City, , Mexico
Ciudad De México, , Mexico
Liège, , Belgium
Trujillo, , Peru
Wilrijk, , Belgium
Concepción, , Chile
Arequipa, , Peru
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported