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Spots Global Cancer Trial Database for A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

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Trial Identification

Brief Title: A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Official Title: SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Study ID: NCT04711252

Study Description

Brief Summary: The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.

Detailed Description: A Randomised, Multicentre, Double-Blind, Phase III study will evaluate the safety and efficacy of AZD9833 (next generation oral SERD) in combination with palbociclib versus anastrozole in combination with palbociclib for the treatment of patients with ER-positive breast cancer. The goal of the study is to demonstrate superiority of AZD9833 over anastrozole in the context of combination with palbociclib in first line setting. INFORMATION FOR TRIAL PARTICIPANTS Researchers are looking for a better way to treat breast cancer. In people with cancer, some cells have grown out of control to form tumours. The trial drugs palbociclib, camizestrant, and anastrozole are designed to work by blocking the cancer's ability to grow. Camizestrant is also called AZD9833. Palbociclib and anastrozole are already available as treatments for people with certain type of breast cancer. In this trial, the researchers want to find out how well taking camizestrant with palbociclib, or anastrozole with palbociclib, works in participants with breast cancer that has ER proteins but does not have overexpression of HER2 protein. The researchers will look at which trial treatments help the participants live longer with cancer before it gets worse. The trial will split participants into 2 groups: * Participants in Group 1 will take camizestrant, palbociclib, and a placebo matched with anastrazole. * Participants in Group 2 will take anastrozole, palbociclib, , and a placebo matched with camizestrant. A placebo looks like a treatment but does not have any medicine in it. A computer program will be used to randomly choose the treatments each participant gets. This helps make sure the groups are chosen fairly. Researchers do this so that comparing the results of each treatment will be as accurate as possible. The participants will take their trial treatments in periods called "cycles". Each cycle will last 28 days. During each cycle, the participants will take: * camizestrant or anastrozole once daily by mouth * palbociclib once daily by mouth for 21 days. Then, they will not take any palbociclib for 7 days Some participants will also get either goserelin or leuprorelin once every month. Participants could get goserelin or leuprorelin if: * They are medically determined yet to reach menopause status * They are male They will get this treatment as an injection under the skin or into a muscle. Goserelin and leuprorelin work by decreasing the amount of sex hormones made by the body which will lead to reduction of ER production. This can help stop breast cancer from growing. Participants will take trial treatment until the cancer gets worse or they leave the trial. Participants will visit their trial site several times throughout the trial. At these visits, the trial doctors will check the health of the participants. They will also take blood samples and do scans of the participants' tumors.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Research Site, Mobile, Alabama, United States

Research Site, Springdale, Arkansas, United States

Research Site, Harbor City, California, United States

Research Site, Solvang, California, United States

Research Site, Lone Tree, Colorado, United States

Research Site, Fort Myers, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, West Palm Beach, Florida, United States

Research Site, Indianapolis, Indiana, United States

Research Site, Baton Rouge, Louisiana, United States

Research Site, Silver Spring, Maryland, United States

Research Site, Boston, Massachusetts, United States

Research Site, Detroit, Michigan, United States

Research Site, Hattiesburg, Mississippi, United States

Research Site, Omaha, Nebraska, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Portland, Oregon, United States

Research Site, West Columbia, South Carolina, United States

Research Site, Sioux Falls, South Dakota, United States

Research Site, Chattanooga, Tennessee, United States

Research Site, Nashville, Tennessee, United States

Research Site, Austin, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Tyler, Texas, United States

Research Site, Fairfax, Virginia, United States

Research Site, Kennewick, Washington, United States

Research Site, Renton, Washington, United States

Research Site, Morgantown, West Virginia, United States

Research Site, Feldkirch, , Austria

Research Site, Salzburg, , Austria

Research Site, Wien, , Austria

Research Site, Anderlecht, , Belgium

Research Site, Edegem, , Belgium

Research Site, Gent, , Belgium

Research Site, Leuven, , Belgium

Research Site, Liège, , Belgium

Research Site, Namur, , Belgium

Research Site, Sint-Niklaas, , Belgium

Research Site, Plovdiv, , Bulgaria

Research Site, Plovdiv, , Bulgaria

Research Site, Shumen, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Edmonton, Alberta, Canada

Research Site, Vancouver, British Columbia, Canada

Research Site, Kitchener, Ontario, Canada

Research Site, London, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Montreal, , Canada

Research Site, Concepcion, , Chile

Research Site, La Serena, , Chile

Research Site, Santiago, , Chile

Research Site, Santiago, , Chile

Research Site, Baoding, , China

Research Site, Beijing, , China

Research Site, Beijing, , China

Research Site, Beijing, , China

Research Site, Bengbu, , China

Research Site, Changchun, , China

Research Site, Changchun, , China

Research Site, Changsha, , China

Research Site, Chengdu, , China

Research Site, Chongqing, , China

Research Site, Dalian, , China

Research Site, Guangzhou, , China

Research Site, Guangzhou, , China

Research Site, Guiyang, , China

Research Site, Haikou, , China

Research Site, Hangzhou, , China

Research Site, Hangzhou, , China

Research Site, Hefei, , China

Research Site, Jinan, , China

Research Site, Lanzhou, , China

Research Site, Linyi, , China

Research Site, Nanchang, , China

Research Site, Nanjing, , China

Research Site, Shanghai, , China

Research Site, Shanghai, , China

Research Site, Shenyang, , China

Research Site, Tianjin, , China

Research Site, Wuhan, , China

Research Site, Wuhan, , China

Research Site, Xi'an, , China

Research Site, Zhengzhou, , China

Research Site, Horovice, , Czechia

Research Site, Hradec Kralove, , Czechia

Research Site, Novy Jicin, , Czechia

Research Site, Praha 10, , Czechia

Research Site, Praha 4, , Czechia

Research Site, Praha 5, , Czechia

Research Site, Besancon Cedex, , France

Research Site, Bordeaux, , France

Research Site, Brest Cedex, , France

Research Site, Caen Cedex 05, , France

Research Site, Dijon, , France

Research Site, Le Mans, , France

Research Site, Lille, , France

Research Site, Montpellier, , France

Research Site, Pierre Benite Cedex, , France

Research Site, Plerin SUR MER, , France

Research Site, Saint-cloud, , France

Research Site, Vandoeuvre Les Nancy, , France

Research Site, Villejuif Cedex, , France

Research Site, Berlin, , Germany

Research Site, Dessau-RoBlau, , Germany

Research Site, Essen, , Germany

Research Site, Freiburg, , Germany

Research Site, Mönchengladbach, , Germany

Research Site, München, , Germany

Research Site, Münster, , Germany

Research Site, Regensburg, , Germany

Research Site, Velbert, , Germany

Research Site, Budapest, , Hungary

Research Site, Budapest, , Hungary

Research Site, Budapest, , Hungary

Research Site, Győr, , Hungary

Research Site, Miskolc, , Hungary

Research Site, Nyíregyháza, , Hungary

Research Site, Szekszárd, , Hungary

Research Site, Zalaegerszeg, , Hungary

Research Site, Ahmedabad, , India

Research Site, Calicut, , India

Research Site, Delhi, , India

Research Site, Faridabad, , India

Research Site, Gurgaon, , India

Research Site, Karamsad, , India

Research Site, Kolkata, , India

Research Site, Madurai, , India

Research Site, Nagpur, , India

Research Site, Nashik, , India

Research Site, Nashik, , India

Research Site, New Delhi, , India

Research Site, Bergamo, , Italy

Research Site, Firenze, , Italy

Research Site, Milan, , Italy

Research Site, Modena, , Italy

Research Site, Napoli, , Italy

Research Site, Novara, , Italy

Research Site, Padova, , Italy

Research Site, Parma, , Italy

Research Site, Prato, , Italy

Research Site, Roma, , Italy

Research Site, Roma, , Italy

Research Site, Rozzano, , Italy

Research Site, Chiba-shi, , Japan

Research Site, Chuo-ku, , Japan

Research Site, Chuo-ku, , Japan

Research Site, Hidaka-shi, , Japan

Research Site, Hirakata-shi, , Japan

Research Site, Isehara-shi, , Japan

Research Site, Kitaadachi-gun, , Japan

Research Site, Koto-ku, , Japan

Research Site, Kumamoto-shi, , Japan

Research Site, Kurashiki shi, , Japan

Research Site, Kurume-shi, , Japan

Research Site, Kyoto-shi, , Japan

Research Site, Nagoya-shi, , Japan

Research Site, Nagoya-shi, , Japan

Research Site, Nishinomiya-shi, , Japan

Research Site, Osaka-shi, , Japan

Research Site, Osaka-shi, , Japan

Research Site, Ota-shi, , Japan

Research Site, Sapporo-shi, , Japan

Research Site, Sendai-shi, , Japan

Research Site, Shimotsuke-shi, , Japan

Research Site, Shinagawa-ku, , Japan

Research Site, Shinjuku-ku, , Japan

Research Site, Suita-shi, , Japan

Research Site, Takasaki-shi, , Japan

Research Site, Tsu-shi, , Japan

Research Site, Tsukuba-shi, , Japan

Research Site, Yokohama-shi, , Japan

Research Site, Busan, , Korea, Republic of

Research Site, Daegu, , Korea, Republic of

Research Site, Goyang-si, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, George Town, , Malaysia

Research Site, Johor Bahru, , Malaysia

Research Site, Kuala Lumpur, , Malaysia

Research Site, Kuala Lumpur, , Malaysia

Research Site, Kuching, , Malaysia

Research Site, Selangor, , Malaysia

Research Site, Del. Cuauhtemoc, , Mexico

Research Site, Estado de México, , Mexico

Research Site, La Paz, , Mexico

Research Site, Mexico City, , Mexico

Research Site, Monterrey, , Mexico

Research Site, Puebla, , Mexico

Research Site, Drammen, , Norway

Research Site, Oslo, , Norway

Research Site, Gdynia, , Poland

Research Site, Konin, , Poland

Research Site, Koszalin, , Poland

Research Site, Lublin, , Poland

Research Site, Olsztyn, , Poland

Research Site, Poznań, , Poland

Research Site, Łódź, , Poland

Research Site, Braga, , Portugal

Research Site, Guimarães, , Portugal

Research Site, Lisboa, , Portugal

Research Site, Lisboa, , Portugal

Research Site, Lisboa, , Portugal

Research Site, Loures, , Portugal

Research Site, Porto, , Portugal

Research Site, Porto, , Portugal

Research Site, Vila Nova de Gaia, , Portugal

Research Site, Kaluga, , Russian Federation

Research Site, Kislino Village, Ryshkovsky Ru, , Russian Federation

Research Site, Moscow, , Russian Federation

Research Site, Moscow, , Russian Federation

Research Site, Moscow, , Russian Federation

Research Site, Moscow, , Russian Federation

Research Site, Saint Petersburg, , Russian Federation

Research Site, Saint-Petersburg, , Russian Federation

Research Site, Saint-Petersburg, , Russian Federation

Research Site, Sankt-Peterburg, , Russian Federation

Research Site, Banská Bystrica, , Slovakia

Research Site, Bratislava, , Slovakia

Research Site, Bratislava, , Slovakia

Research Site, Prešov, , Slovakia

Research Site, Trencin, , Slovakia

Research Site, Barcelona, , Spain

Research Site, Barcelona, , Spain

Research Site, Jaén, , Spain

Research Site, Lleida, , Spain

Research Site, Madrid, , Spain

Research Site, Madrid, , Spain

Research Site, Malaga, , Spain

Research Site, Pamplona, , Spain

Research Site, Santander, , Spain

Research Site, Sevilla, , Spain

Research Site, Valencia, , Spain

Research Site, Liestal, , Switzerland

Research Site, Zürich, , Switzerland

Research Site, Kaohsiung, , Taiwan

Research Site, Kaohsiung, , Taiwan

Research Site, Taichung, , Taiwan

Research Site, Tainan, , Taiwan

Research Site, Taipei City, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Taoyuan, , Taiwan

Research Site, Adana, , Turkey

Research Site, Ankara, , Turkey

Research Site, Ankara, , Turkey

Research Site, Ankara, , Turkey

Research Site, Ankara, , Turkey

Research Site, Izmir, , Turkey

Research Site, Izmir, , Turkey

Research Site, Kayseri, , Turkey

Research Site, Birmingham, , United Kingdom

Research Site, Cambridge, , United Kingdom

Research Site, Colchester, , United Kingdom

Research Site, Leeds, , United Kingdom

Research Site, Nottingham, , United Kingdom

Research Site, Surrey, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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