Breast Cancer Clinical Trial

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

Summary

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib or abemaciclib) 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

View Full Description

Full Description

A Randomised, Multicentre, Double-Blind, Phase III study will evaluate the safety and efficacy of AZD9833 (next generation oral SERD) in combination with CDK4/6 inhibitor (palbociclib or abemaciclib) versus aromatase inhibitor (anastrozole or letrozole) in combination with CDK4/6 inhibitor for the treatment of patients with HR-positive, HER2- negative metastatic breast cancer with detectable ESR1 Mutation. The goal of the study is to demonstrate superiority of AZD9833 over anastrozole or letrozole in the context of combination with palbociclib or abemaciclib

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent.
Documentation of histologically confirmed diagnosis of estrogen receptor positive (ER+) /HER2- breast cancer based on local laboratory results.
Currently on AI (letrozole or anastrozole) + CDK4/6 inhibitor (palbociclib or abemaciclib) ± LHRH as the initial endocrine based treatment for advanced disease
Eastern Cooperative Oncology Group performance status of 0 or 1.
ESR1m positive detected by central testing of ctDNA
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Adequate organ and marrow function

Exclusion Criteria:

Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.
Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
Patient with known or family history of severe heart disease
Previous treatment with AZD9833, investigational SERDs or fulvestrant.
Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
Persistent non-haematological toxicities (CTCAE Grade > 2) caused by CDK4/6 inhibitor and/or AI treatment.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

302

Study ID:

NCT04964934

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 211 Locations for this study

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Phoenix Arizona, 85054, United States
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Hot Springs National Park Arkansas, 71913, United States
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Little Rock Arkansas, 72205, United States
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Long Beach California, 90806, United States
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San Diego California, 92123, United States
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Santa Rosa California, 92805, United States
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Denver Colorado, 80218, United States
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Grand Junction Colorado, 81501, United States
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Lone Tree Colorado, 80124, United States
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Fort Myers Florida, 33901, United States
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Jacksonville Florida, 32224, United States
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Jacksonville Florida, 32256, United States
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Saint Petersburg Florida, 33705, United States
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Atlanta Georgia, 30322, United States
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Atlanta Georgia, 30342, United States
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Fort Wayne Indiana, 46804, United States
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Indianapolis Indiana, 46250, United States
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Baltimore Maryland, 21202, United States
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Boston Massachusetts, 02215, United States
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Detroit Michigan, 48202, United States
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Grand Rapids Michigan, 49503, United States
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Rochester Minnesota, 55905, United States
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Saint Louis Missouri, 63110, United States
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Billings Montana, 59101, United States
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Omaha Nebraska, 68130, United States
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Camden New Jersey, 08103, United States
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Ridgewood New Jersey, 07450, United States
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New York New York, 10065, United States
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Blue Ash Ohio, 45242, United States
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Columbus Ohio, 43219, United States
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Philadelphia Pennsylvania, 19104, United States
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Pittsburgh Pennsylvania, 15213, United States
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Greenville South Carolina, 29607, United States
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West Columbia South Carolina, 29169, United States
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Knoxville Tennessee, 37916, United States
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Memphis Tennessee, 38120, United States
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Nashville Tennessee, 37203, United States
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Bedford Texas, 76022, United States
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Dallas Texas, 75246, United States
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Houston Texas, 77024, United States
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Irving Texas, 75063, United States
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Longview Texas, 75601, United States
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Lubbock Texas, 79410, United States
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San Antonio Texas, 78240, United States
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Norfolk Virginia, 23502, United States
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Tacoma Washington, 98405, United States
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Birtinya , 4575, Australia
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Darlinghurst , 2010, Australia
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Subiaco , 6008, Australia
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Graz , 8036, Austria
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Innsbruck , 6020, Austria
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Wien , 1090, Austria
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Wien , 1130, Austria
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Haskovo , 6300, Bulgaria
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Panagyurishte , 4500, Bulgaria
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Pleven , 5804, Bulgaria
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Plovdiv , 4004, Bulgaria
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Sofia , 1303, Bulgaria
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Sofia , 1330, Bulgaria
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Sofia , 1407, Bulgaria
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Sofia , 1527, Bulgaria
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Sofia , , Bulgaria
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Calgary Alberta, T2N 4, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Montreal Quebec, H1T 2, Canada
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Montreal Quebec, H2X 0, Canada
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Montreal Quebec, H3T 1, Canada
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Ottawa , K1H 8, Canada
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Quebec , G1S 4, Canada
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Avignon Cedex 09 , 84918, France
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Brest , 29200, France
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Clermont-Ferrand , 63050, France
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Limoges , 83000, France
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Lorient cedex , 56322, France
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Lyon Cedex 08 , 69373, France
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Marseille , 13273, France
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Metz-Tessy , 74370, France
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Nimes , 30029, France
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Paris Cedex 5 , 75248, France
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Rouen , 76021, France
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Saint Herblain Cedex , 44805, France
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Saint-cloud , 92210, France
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Toulouse , 31100, France
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Tours , 37000, France
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Vandoeuvre les Nancy , 54519, France
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Vantoux , 57070, France
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Ansbach , 91522, Germany
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Aschaffenburg , 63739, Germany
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Augsburg , 86156, Germany
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Bonn , 53111, Germany
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Chemnitz , 09116, Germany
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Dresden , 01307, Germany
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Erlangen , 91054, Germany
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Essen , 45130, Germany
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Leipzig , 4103, Germany
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Mannheim , 68167, Germany
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München , 80634, Germany
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Paderborn , 33098, Germany
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Ravensburg , 88212, Germany
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Ulm , 89075, Germany
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Budapest , 1062, Hungary
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Budapest , 1122, Hungary
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Miskolc , 3526, Hungary
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Szekszárd , 7100, Hungary
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Szolnok , 5004, Hungary
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Zalaegerszeg , 8900, Hungary
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Bergamo , 24127, Italy
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Bologna , 40138, Italy
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Milano , 20132, Italy
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Napoli , 80131, Italy
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Padova , 35128, Italy
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Roma , 00168, Italy
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Rozzano , 20089, Italy
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Chiba-shi , 260-8, Japan
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Chuo-ku , 104-0, Japan
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Hidaka-shi , 350-1, Japan
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Hirakata-shi , 573-1, Japan
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Kitaadachi-gun , 362-0, Japan
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Koto-ku , 135-8, Japan
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Kumamoto-shi , 860-8, Japan
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Matsuyama-shi , 791-0, Japan
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Nagoya-shi , 464-8, Japan
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Nagoya-shi , 467-0, Japan
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Niigata-shi , 951-8, Japan
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Osaka-shi , 540-0, Japan
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Osaka-shi , 541-8, Japan
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Ota-shi , 373-8, Japan
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Sapporo-shi , 003-0, Japan
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Shinagawa-ku , 142-8, Japan
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Shinjuku-ku , 162-8, Japan
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Takasaki-shi , 370-0, Japan
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Tsukuba , 305-8, Japan
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Yokohama-shi , 241-8, Japan
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Cheonan-si , 31151, Korea, Republic of
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Daegu , 42415, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seongnam-si , 463-7, Korea, Republic of
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Seoul , 02841, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06273, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Gdynia , 81-51, Poland
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Konin , 62-50, Poland
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Koszalin , 75-58, Poland
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Olsztyn , 10-51, Poland
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Poznan , 60-69, Poland
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Skórzewo , 60-18, Poland
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Tomaszów Mazowiecki , 97-20, Poland
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Warszawa , 02-78, Poland
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Łódź , 90-30, Poland
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Guimarães , 4835-, Portugal
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Lisboa , 1400-, Portugal
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Lisboa , 1449-, Portugal
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Lisboa , 1500-, Portugal
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Lisboa , 1649-, Portugal
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Loures , 2674-, Portugal
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Porto , 4099-, Portugal
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Porto , 4200-, Portugal
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Porto , 4200-, Portugal
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Vila Nova de Gaia , 4434-, Portugal
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Moscow , 11112, Russian Federation
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Moscow , 12909, Russian Federation
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Moscow , 14342, Russian Federation
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Nizhny Novgorod , 60312, Russian Federation
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Podolsk , 14210, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Sankt-Peterburg , 19775, Russian Federation
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St. Petersburg , 19401, Russian Federation
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Barcelona , 8035, Spain
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L'Hospitalet de Llobregat , 08908, Spain
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La Coruna , 15006, Spain
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Madrid , 28040, Spain
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Madrid , 28041, Spain
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Murcia , 30008, Spain
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Málaga , 29010, Spain
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Sevilla , 41013, Spain
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Valencia , 46010, Spain
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Bern , CH-30, Switzerland
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Chur , CH-70, Switzerland
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Winterthur , 8401, Switzerland
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Kaohsiung city , 833, Taiwan
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Taichung , 40705, Taiwan
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Tainan , 70403, Taiwan
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Tainan , 710, Taiwan
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Taipei 112 , , Taiwan
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Taipei City , 110, Taiwan
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Taipei , 100, Taiwan
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Taipei , 11259, Taiwan
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Taipei , 11490, Taiwan
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Taoyuan , 333, Taiwan
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Adana , 01120, Turkey
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Ankara , 06010, Turkey
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Ankara , 06100, Turkey
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Ankara , 06340, Turkey
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Ankara , 06520, Turkey
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İstanbul , 34457, Turkey
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Izmir , 35100, Turkey
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Izmir , 35360, Turkey
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Kayseri , 38039, Turkey
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Blackpool , FY3 8, United Kingdom
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Cambridge , CB2 0, United Kingdom
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Guildford , , United Kingdom
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Liverpool , L7 3E, United Kingdom
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London , SW3 6, United Kingdom
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London , WC1N , United Kingdom
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Newport , NP10 , United Kingdom
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Nottingham , NG5 1, United Kingdom
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Portsmouth , PO6 3, United Kingdom
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Reading , RG2 9, United Kingdom
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Sheffield , S10 2, United Kingdom
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Sutton , SM2 5, United Kingdom
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Taunton , TA1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

302

Study ID:

NCT04964934

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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