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Spots Global Cancer Trial Database for A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

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Trial Identification

Brief Title: A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

Official Title: SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer

Study ID: NCT04214288

Interventions

AZD9833
Fulvestrant

Study Description

Brief Summary: This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

Detailed Description: Post-menopausal women with histologically or cytologically confirmed metastatic or loco-regionally recurrent ER-positive HER2-negative breast cancer before randomization and fulfilling all of the inclusion criteria and none of the exclusion criteria will be included. After the screening visit and confirmation of eligibility, patients will be randomly assigned in a 1:1:1:1 ratio to receive 1 of the following 4 treatments, consisting of 4-week treatment cycles until disease progression (assessed by the Investigator as defined by Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1): * AZD9833 (Dose A) * AZD9833 (Dose B) * AZD9833 (Dose C) * Fulvestrant (500 mg) During the treatment period, patients will have scheduled visits until treatment discontinuation. After the end of treatment, patients will attend 2 safety follow-up visits (at the time of treatment discontinuation and 28 days later) and will continue to be followed for survival. As of December 2020, the Sponsor stopped enrolment to Dose C.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Research Site, Birmingham, Alabama, United States

Research Site, Long Beach, California, United States

Research Site, Fort Myers, Florida, United States

Research Site, Saint Petersburg, Florida, United States

Research Site, Lincoln, Nebraska, United States

Research Site, Canton, Ohio, United States

Research Site, Chattanooga, Tennessee, United States

Research Site, Nashville, Tennessee, United States

Research Site, Eagle River, Wisconsin, United States

Research Site, Brasschaat, , Belgium

Research Site, Charleroi, , Belgium

Research Site, Gent, , Belgium

Research Site, Haine-Saint-Paul, , Belgium

Research Site, Leuven, , Belgium

Research Site, Libramont-Chevigny, , Belgium

Research Site, Namur, , Belgium

Research Site, Greenfield Park, Quebec, Canada

Research Site, Montreal, Quebec, Canada

Research Site, Montreal, Quebec, Canada

Research Site, Paris, , France

Research Site, Vandoeuvre les Nancy, , France

Research Site, Batumi, , Georgia

Research Site, Tbilisi, , Georgia

Research Site, Tbilisi, , Georgia

Research Site, Tbilisi, , Georgia

Research Site, Tbilisi, , Georgia

Research Site, Tbilisi, , Georgia

Research Site, Berlin, , Germany

Research Site, Düsseldorf, , Germany

Research Site, Essen, , Germany

Research Site, Budapest, , Hungary

Research Site, Debrecen, , Hungary

Research Site, Kaposvár, , Hungary

Research Site, Kecskemét, , Hungary

Research Site, Nyíregyháza, , Hungary

Research Site, Pécs, , Hungary

Research Site, Szeged, , Hungary

Research Site, Jerusalem, , Israel

Research Site, Jerusalem, , Israel

Research Site, Nahariya, , Israel

Research Site, Petah Tikva, , Israel

Research Site, Bologna, , Italy

Research Site, Catanzaro, , Italy

Research Site, Meldola, , Italy

Research Site, Messina, , Italy

Research Site, Milano, , Italy

Research Site, Milan, , Italy

Research Site, Monza, , Italy

Research Site, Napoli, , Italy

Research Site, Roma, , Italy

Research Site, Umbria, , Italy

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

Research Site, Incheon, , Korea, Republic of

Research Site, Bydgoszcz, , Poland

Research Site, Piła, , Poland

Research Site, Rzeszów, , Poland

Research Site, Skorzewo, , Poland

Research Site, Warszawa, , Poland

Research Site, Łódź, , Poland

Research Site, Almada, , 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, Kazan, , Russian Federation

Research Site, Krasnodar, , Russian Federation

Research Site, Kursk, , Russian Federation

Research Site, Moscow, , Russian Federation

Research Site, Moscow, , Russian Federation

Research Site, Pyatigorsk, , Russian Federation

Research Site, Ryazan, , Russian Federation

Research Site, Saint Petersburg, , Russian Federation

Research Site, Saint-Petersburg, , Russian Federation

Research Site, Volgograd, , Russian Federation

Research Site, Barcelona, , Spain

Research Site, Barcelona, , Spain

Research Site, Madrid, , Spain

Research Site, Madrid, , Spain

Research Site, Sevilla, , Spain

Research Site, Zaragoza, , Spain

Research Site, Cherkasy, , Ukraine

Research Site, Chernivtsі, , Ukraine

Research Site, Dnipro, , Ukraine

Research Site, Kyiv, , Ukraine

Research Site, M. Kyiv, , Ukraine

Research Site, S. Khodosivka, , Ukraine

Research Site, Uzhhorod, , Ukraine

Research Site, Derby, , United Kingdom

Research Site, Leicester, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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