Studying a New PARP Inhibitor and Hormonal Therapy to Treat HER2-negative, HR-positive Metastatic Breast Cancer with a BRCA1, BRCA2, or PALB2 Mutation (EvoPAR BR01)
Treatment
Treatment study for HER2-negative, HR-positive metastatic breast cancer with a BRCA1, BRCA2 or PALB2 mutation
Clinicaltrials.gov identifier:NCT06380751
Study Contact Information:
Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com
About the Study
EvoPAR-BR01 is looking at two investigational drugs for treating , , breast cancer in people with a , or inherited mutation. The study is enrolling patients who have not yet been treated for breast cancer. Saruparib is a new (a type of ). Camizestrant is an receptor degrader (a type of hormonal therapy). Participants will be randomly assigned to one of three groups. Each group will receive a different combination of treatments to learn which combination leads to the best survival and fewest side effects.
This Study is Open To:
People with breast cancer may be eligible if they meet all of the following:
- have , metastatic breast cancer.
- have an inherited , or mutation.
- have not received any treatment in the setting, other than hormonal therapy within 28 days of starting the study.
This Study is NOT Open To:
People who:
- have received treatment in the setting except for hormonal therapy for 28 days or less before joining the study.
- have brain or central nervous system spread.
- have a bleeding disorder.
- have uncontrolled disease or infection.
- have a history of diagnosis with another type of cancer.
What the Study Involves
Participants will be assigned by chance to one of three groups:
Group 1:
- Saruparib orally plus Camizestrant orally.
- Both drugs are investigational agents not yet approved by the .
Group 2:
- CDK4/6 inhibitor orally plus hormonal therapy (oral or intramuscular depending on the drug chosen by the patient's oncologist).
- CDK4/6 inhibitors are a type of commonly used for breast cancer. Participants' oncologist will choose from one of the three FDA-approved agents: Abemiciclib (Verzenio), Palbociclib (Ibrance), or Ribociclib (Kisqali).
- Participants' oncologist will choose from the following FDA-approved agents: Fulvestrant (Faslodex) intramuscular injection, Letrozole (Femara) orally, Anastrozole (Arimidex) orally, or Exemestane (Aromasin) orally.
Group 3:
- CDK4/6 inhibitor orally plus Camizestrant orally.
Participants will be monitored over the course of the study for response to treatment and side effects. Participants will continue to receive treatment unless the cancer gets worse, they experience intolerable side effects or they decide to withdraw from the study.
Study Contact Information:
Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com
Locations:
Arizona
City: Gilbert RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
California
City: Los Angeles RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: Newport Beach RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Colorado
City: Aurora RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: Grand Junction RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Florida
City: Hollywood RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Illinois
City: Chicago RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: Urbana RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Massachusetts
City: Boston RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Maryland
City: Silver Spring RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Michigan
City: Detroit RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: Royal Oak RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
New Jersey
City: Camden RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
New York
City: Bronx RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: Mineola RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: New Hyde Park RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: New York RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: New York RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: New York RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: Shirley RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Pennsylvania
City: Philadelphia RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Tennessee
City: Chattanooga RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: Nashville RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Texas
City: Houston RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
City: Houston RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Virginia
City: Norfolk RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Washington
City: Tacoma RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
West Virginia
City: Morgantown RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Puerto Rico
City: San Juan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Other Countries
Country: Argentina
City: Ciudad Autónoma Buenos Aires RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Argentina
City: Ciudad de Buenos Aires RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Australia
City: Darlinghurst RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Australia
City: Darlinghurst RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Australia
City: Melbourne RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Austria
City: Graz RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Austria
City: Linz RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Austria
City: Wien RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: Cachoeira De Itapemirim RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: Curitiba RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: Fortaleza RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: Goiânia RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: Jaú RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: Porto Alegre RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: Ribeirão Preto RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: Salvador RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: Sao Paulo RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Brazil
City: São Paulo RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Chile
City: Providencia RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Chile
City: Recoleta RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Chile
City: Talca RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Chile
City: Vina del Mar RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Beijing RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Bengbu RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Changchun RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Changchun RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Changsha RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Changsha RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Chengdu RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Chengdu RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Chongqing RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Foshan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Fuzhou RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Guangzhou RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Guangzhou RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Guangzhou RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Hangzhou RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Hangzhou RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Harbin RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Hefei RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Jining RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Liuzhou RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Luoyang RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Nanchang RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Nanchang RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Nanjing RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Shandong RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Shanghai RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Shenyang RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Shijiazhuang RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Tianjin RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Wuhan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Wuhan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Wuhan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Xi'an RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Xi'an RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Xiamen RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Xiangfan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Xinxiang RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: China
City: Zhengzhou RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: France
City: Besançon Cedex RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: France
City: Paris RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: France
City: Rouen RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: France
City: Toulouse RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Aachen RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Augsburg RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Berlin RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Düsseldorf RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Dessau-Roßlau RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Hamburg RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Hannover RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Heidelberg RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Kiel RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Leipzig RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: Ludwigsburg RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Germany
City: München RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Hungary
City: Miskolc RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: India
City: Delhi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: India
City: Kolkata RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: India
City: Mumbai RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: India
City: Mysuru RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: India
City: Nagpur RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: India
City: Nashik RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: India
City: New Delhi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: India
City: Surat RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Israel
City: Jerusalem RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Israel
City: Jerusalem RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Israel
City: Tel Aviv RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Italy
City: Bologna RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Italy
City: Milano RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Italy
City: Milano RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Italy
City: Napoli RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Italy
City: Padova RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Italy
City: Rome RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Italy
City: Rozzano RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Chiba-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Hidaka-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Hirakata-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Isehara-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Kagoshima-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Kashiwa RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Koto-ku RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Kumamoto-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Kyoto-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Matsuyama-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Nagoya-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Nagoya-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Nagoya-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Osaka-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Ota-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Sapporo-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Sendai-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Shinagawa-ku RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Suita-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Sunto-gun RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Takasaki-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Tsu-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Japan
City: Yokohama-shi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Korea, Republic of
City: Daegu RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Korea, Republic of
City: Seongnam-si RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Korea, Republic of
City: Seoul RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Korea, Republic of
City: Seoul RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Korea, Republic of
City: Seoul RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Korea, Republic of
City: Seoul RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Korea, Republic of
City: Seoul RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Poland
City: Poznań RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Poland
City: Warszawa RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Poland
City: Łódź RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Portugal
City: Matosinhos RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Spain
City: Barcelona RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Spain
City: Granada RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Spain
City: L'Hospitalet de Llobregat RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Spain
City: Málaga RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Spain
City: Pamplona RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Spain
City: Sevilla RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Spain
City: Valencia RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Taiwan
City: New Taipei RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Taiwan
City: Taichung RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Taiwan
City: Tainan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Taiwan
City: Taipei RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Taiwan
City: Taipei RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Taiwan
City: Taipei RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Taiwan
City: Taoyuan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Thailand
City: Bangkok RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Thailand
City: Bangkok RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Thailand
City: Dusit RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Thailand
City: Hat Yai RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Thailand
City: Ratchathewi RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Turkey
City: Adapazari RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Turkey
City: Altındağ-Ankara RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Turkey
City: Istanbul RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: Turkey
City: Kayseri RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: United Kingdom
City: Cambridge RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: United Kingdom
City: Guildford RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: United Kingdom
City: London RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: United Kingdom
City: Manchester RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Country: United Kingdom
City: Taunton RECRUITING
Facility: Research Site
Contact Info:
No contact info provided
Treatment
Treatment study for HER2-negative, HR-positive metastatic breast cancer with a BRCA1, BRCA2 or PALB2 mutation
Clinicaltrials.gov identifier:NCT06380751
Study Contact Information:
Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com