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Spots Global Cancer Trial Database for Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

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Trial Identification

Brief Title: Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Official Title: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

Study ID: NCT04964934

Study Description

Brief Summary: The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

Detailed Description: Breast cancer is the most common type of cancer among women. In people with breast cancer, the body is not able to control the growth of some cells. These extra cells can form tumors in the breast. When tumor cells move to different parts of the body this is called advanced cancer. Researchers are looking for better ways to treat advanced breast cancer. This trial will look at six drugs: palbociclib, abemaciclib, ribociclib, letrozole, anastrozole, and AZD9833. AZD9833 is the trial drug, and is the only drug not yet approved for use. Palbociclib, abemaciclib and ribociclib work in the same way and are a type of cancer drug called a CDK4/6 inhibitor. Letrozole and anastrozole work in the same way and are both a type of cancer drug called an aromatase inhibitor (AI). CDK4/6 inhibitors and AIs work together to block the tumor's ability to grow. These drugs have been approved for combined use in people with advanced breast cancer that is HR-positive and HER2-negative. But if people get mutations in the ESR1 gene, it can make the AI and CDK4/6 inhibitor treatment work less well. The trial drug, AZD9833, is designed to work with a CDK4/6 inhibitor in the same way that an AI does. Researchers think that AZD9833 might work better with a CDK4/6 inhibitor than an AI does in people who get mutations in their ESR1 gene. Participants in this trial will have already been receiving one of the following combinations of a CDK4/6 inhibitor and an AI: * palbociclib + anastrozole * palbociclib + letrozole * abemaciclib + anastrozole * abemaciclib + letrozole * ribociclib + anastrozole * ribociclib + letrozole During the trial, participants will remain on the same CDK4/6 inhibitor that they were taking before the trial. In this trial, the researchers want to find out how well switching a participant with an ESR1 gene mutation from an AI (letrozole or anastrozole) to AZD9833 works in the treatment of advanced breast cancer that is HR-positive and HER2-negative. The researchers will look at which trial treatment helps the participants live longer with the cancer before it gets worse. The researchers also want to know more about how safe AZD9833 is. The trial participants will be split into 2 groups: * Participants in Group A will receive AZD9833, a CDK4/6 inhibitor, and a placebo * Participants in Group B will receive an AI, a CDK4/6 inhibitor, and a placebo 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 over 28-day cycles, with a placebo and either AZD9833 or an AI taken once daily by mouth for all 28 days. If the participant is taking abemaciclib, they will take it twice daily by mouth for all 28 days. If the participant is taking palbociclib or ribociclib, they will take it once daily by mouth for 21 days and then stop taking it for the final 7 days of the cycle. The participant will then repeat the 28-day cycle receiving the trial treatment in the same way for as long as they are in the trial. Participants will visit their trial site regularly 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. Participants will take their trial treatment until their cancer gets worse or they decide to leave the trial. \*Palbociclib and Abemacliclib cohorts are currently ongoing. Ribociclib cohort will be open pending on availability of the data.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Research Site, Phoenix, Arizona, United States

Research Site, Hot Springs National Park, Arkansas, United States

Research Site, Little Rock, Arkansas, United States

Research Site, Long Beach, California, United States

Research Site, San Diego, California, United States

Research Site, Santa Rosa, California, United States

Research Site, Stanford, California, United States

Research Site, Denver, Colorado, United States

Research Site, Grand Junction, Colorado, United States

Research Site, Lone Tree, Colorado, United States

Research Site, Fort Lauderdale, Florida, United States

Research Site, Fort Myers, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Saint Petersburg, Florida, United States

Research Site, West Palm Beach, Florida, United States

Research Site, Atlanta, Georgia, United States

Research Site, Atlanta, Georgia, United States

Research Site, Atlanta, Georgia, United States

Research Site, Atlanta, Georgia, United States

Research Site, Chicago, Illinois, United States

Research Site, Oak Lawn, Illinois, United States

Research Site, Park Ridge, Illinois, United States

Research Site, Park Ridge, Illinois, United States

Research Site, Fort Wayne, Indiana, United States

Research Site, Indianapolis, Indiana, United States

Research Site, Baltimore, Maryland, United States

Research Site, Boston, Massachusetts, United States

Research Site, Fairhaven, Massachusetts, United States

Research Site, Foxboro, Massachusetts, United States

Research Site, Milford, Massachusetts, United States

Research Site, South Weymouth, Massachusetts, United States

Research Site, Detroit, Michigan, United States

Research Site, Grand Rapids, Michigan, United States

Research Site, Rochester, Minnesota, United States

Research Site, Oxford, Mississippi, United States

Research Site, Kansas City, Missouri, United States

Research Site, Saint Louis, Missouri, United States

Research Site, Billings, Montana, United States

Research Site, Omaha, Nebraska, United States

Research Site, Camden, New Jersey, United States

Research Site, Clifton, New Jersey, United States

Research Site, Ridgewood, New Jersey, United States

Research Site, Bronx, New York, United States

Research Site, Brooklyn, New York, United States

Research Site, East Syracuse, New York, United States

Research Site, New Hyde Park, New York, United States

Research Site, New York, New York, United States

Research Site, New York, New York, United States

Research Site, New York, New York, United States

Research Site, Shirley, New York, United States

Research Site, Goldsboro, North Carolina, United States

Research Site, Blue Ash, Ohio, United States

Research Site, Canton, Ohio, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Columbus, Ohio, United States

Research Site, Portland, Oregon, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, York, Pennsylvania, United States

Research Site, Greenville, South Carolina, United States

Research Site, West Columbia, South Carolina, United States

Research Site, Knoxville, Tennessee, United States

Research Site, Memphis, Tennessee, United States

Research Site, Nashville, Tennessee, United States

Research Site, Bedford, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Irving, Texas, United States

Research Site, Longview, Texas, United States

Research Site, Lubbock, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Salt Lake City, Utah, United States

Research Site, Midlothian, Virginia, United States

Research Site, Norfolk, Virginia, United States

Research Site, Tacoma, Washington, United States

Research Site, Waukesha, Wisconsin, United States

Research Site, Birtinya, , Australia

Research Site, Darlinghurst, , Australia

Research Site, Subiaco, , Australia

Research Site, Graz, , Austria

Research Site, Innsbruck, , Austria

Research Site, Salzburg, , Austria

Research Site, Wien, , Austria

Research Site, Wien, , Austria

Research Site, Leuven, , Belgium

Research Site, Liège, , Belgium

Research Site, Namur, , Belgium

Research Site, Haskovo, , Bulgaria

Research Site, Panagyurishte, , Bulgaria

Research Site, Pleven, , Bulgaria

Research Site, Plovdiv, , Bulgaria

Research Site, Plovdiv, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Sofia, , Bulgaria

Research Site, Calgary, Alberta, Canada

Research Site, Vancouver, British Columbia, Canada

Research Site, Levis, Quebec, Canada

Research Site, Montreal, Quebec, Canada

Research Site, Montreal, Quebec, Canada

Research Site, Montreal, Quebec, Canada

Research Site, Ottawa, , Canada

Research Site, Quebec, , Canada

Research Site, Avignon Cedex 09, , France

Research Site, Brest, , France

Research Site, Clermont-Ferrand, , France

Research Site, Dijon, , France

Research Site, Limoges, , France

Research Site, Lorient cedex, , France

Research Site, Lyon Cedex 08, , France

Research Site, Marseille, , France

Research Site, Metz-Tessy, , France

Research Site, Nimes, , France

Research Site, Paris Cedex 5, , France

Research Site, Rouen, , France

Research Site, Saint Herblain Cedex, , France

Research Site, Saint-cloud, , France

Research Site, Toulouse, , France

Research Site, Tours, , France

Research Site, Vandoeuvre les Nancy, , France

Research Site, Vantoux, , France

Research Site, Villejuif Cedex, , France

Research Site, Ansbach, , Germany

Research Site, Aschaffenburg, , Germany

Research Site, Augsburg, , Germany

Research Site, Bonn, , Germany

Research Site, Chemnitz, , Germany

Research Site, Dresden, , Germany

Research Site, Erlangen, , Germany

Research Site, Essen, , Germany

Research Site, Freiburg, , Germany

Research Site, Immenstadt, , Germany

Research Site, Koblenz, , Germany

Research Site, Leipzig, , Germany

Research Site, Mannheim, , Germany

Research Site, München, , Germany

Research Site, Paderborn, , Germany

Research Site, Ratingen, , Germany

Research Site, Ravensburg, , Germany

Research Site, Regensburg, , Germany

Research Site, Stade, , Germany

Research Site, Tübingen, , Germany

Research Site, Ulm, , Germany

Research Site, Budapest, , Hungary

Research Site, Budapest, , Hungary

Research Site, Miskolc, , Hungary

Research Site, Szekszárd, , Hungary

Research Site, Szolnok, , Hungary

Research Site, Zalaegerszeg, , Hungary

Research Site, Beer Sheva, , Israel

Research Site, Haifa, , Israel

Research Site, Jerusalem, , Israel

Research Site, Petah Tikva, , Israel

Research Site, Ramat Gan, , Israel

Research Site, Bergamo, , Italy

Research Site, Bologna, , Italy

Research Site, Firenze, , Italy

Research Site, Meldola, , Italy

Research Site, Milano, , Italy

Research Site, Milan, , Italy

Research Site, Misterbianco, , Italy

Research Site, Napoli, , Italy

Research Site, Padova, , Italy

Research Site, Roma, , Italy

Research Site, Rozzano, , Italy

Research Site, Chiba-shi, , Japan

Research Site, Chuo-ku, , Japan

Research Site, Hidaka-shi, , Japan

Research Site, Hirakata-shi, , Japan

Research Site, Kitaadachi-gun, , Japan

Research Site, Koto-ku, , Japan

Research Site, Kumamoto-shi, , Japan

Research Site, Matsuyama-shi, , Japan

Research Site, Nagoya-shi, , Japan

Research Site, Nagoya-shi, , Japan

Research Site, Niigata-shi, , Japan

Research Site, Osaka-shi, , Japan

Research Site, Osaka-shi, , Japan

Research Site, Ota-shi, , Japan

Research Site, Sapporo-shi, , Japan

Research Site, Shinagawa-ku, , Japan

Research Site, Shinjuku-ku, , Japan

Research Site, Takasaki-shi, , Japan

Research Site, Takatsuki-shi, , Japan

Research Site, Tsukuba, , Japan

Research Site, Yokohama-shi, , Japan

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

Research Site, Daegu, , Korea, Republic of

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

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

Research Site, Seongnam-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, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Drammen, , Norway

Research Site, Oslo, , Norway

Research Site, Bydgoszcz, , Poland

Research Site, Gdynia, , Poland

Research Site, Konin, , Poland

Research Site, Koszalin, , Poland

Research Site, Lublin, , Poland

Research Site, Olsztyn, , Poland

Research Site, Poznan, , Poland

Research Site, Rzeszów, , Poland

Research Site, Tomaszów Mazowiecki, , Poland

Research Site, Warszawa, , Poland

Research Site, Łódź, , Poland

Research Site, Guimarães, , Portugal

Research Site, Lisboa, , 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, Porto, , Portugal

Research Site, Vila Nova de Gaia, , Portugal

Research Site, Moscow, , Russian Federation

Research Site, Moscow, , Russian Federation

Research Site, Moscow, , Russian Federation

Research Site, Nizhny Novgorod, , Russian Federation

Research Site, Podolsk, , Russian Federation

Research Site, Saint Petersburg, , Russian Federation

Research Site, Sankt-Peterburg, , Russian Federation

Research Site, St. Petersburg, , Russian Federation

Research Site, Banská Bystrica, , Slovakia

Research Site, Bratislava, , Slovakia

Research Site, Kosice, , Slovakia

Research Site, Michalovce, , Slovakia

Research Site, Partizanske, , Slovakia

Research Site, Badalona, , Spain

Research Site, Barcelona, , Spain

Research Site, L'Hospitalet de Llobregat, , Spain

Research Site, La Coruna, , Spain

Research Site, Madrid, , Spain

Research Site, Madrid, , Spain

Research Site, Murcia, , Spain

Research Site, Málaga, , Spain

Research Site, Sant Joan Despi, , Spain

Research Site, Sevilla, , Spain

Research Site, Valencia, , Spain

Research Site, Bern, , Switzerland

Research Site, Chur, , Switzerland

Research Site, Winterthur, , Switzerland

Research Site, Kaohsiung city, , Taiwan

Research Site, Taichung, , Taiwan

Research Site, Tainan, , Taiwan

Research Site, Tainan, , Taiwan

Research Site, Taipei 112, , Taiwan

Research Site, Taipei City, , Taiwan

Research Site, Taipei, , 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, İstanbul, , Turkey

Research Site, Izmir, , Turkey

Research Site, Izmir, , Turkey

Research Site, Kadıkoy/Istanbul, , Turkey

Research Site, Karsiyaka, , Turkey

Research Site, Kayseri, , Turkey

Research Site, Blackpool, , United Kingdom

Research Site, Cambridge, , United Kingdom

Research Site, Guildford, , United Kingdom

Research Site, Liverpool, , United Kingdom

Research Site, London, , United Kingdom

Research Site, London, , United Kingdom

Research Site, Manchester, , United Kingdom

Research Site, Newport, , United Kingdom

Research Site, Nottingham, , United Kingdom

Research Site, Portsmouth, , United Kingdom

Research Site, Reading, , United Kingdom

Research Site, Sheffield, , United Kingdom

Research Site, Sutton, , United Kingdom

Research Site, Taunton, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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