RecruitingPhase 3NCT07647328

A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer

SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients


Sponsor

AstraZeneca

Enrollment

150 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.


Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Camizestrant and a drug called Ribociclib for people with er-positive, her2-negative breast cancer. The study is currently recruiting participants at 84 locations. People eligible for this study include aged 18 Years to 130 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamizestrant

Patients will receive the standard dose of camizestrant once daily as oral tablets

DRUGRibociclib

Patients will receive the standard dose of ribociclib once daily as oral tablets


Locations(84)

Research Site

Duarte, California, United States

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Palo Alto, California, United States

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Marietta, Georgia, United States

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Evanston, Illinois, United States

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Edgewood, Kentucky, United States

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Louisville, Kentucky, United States

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Reno, Nevada, United States

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Sioux Falls, South Dakota, United States

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Nashville, Tennessee, United States

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Fort Worth, Texas, United States

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Kingwood, Texas, United States

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Midlothian, Virginia, United States

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Angers, France

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Bayonne, France

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Bobigny, France

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Caen, France

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Chambray-lès-Tours, France

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Grenoble, France

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Montpellier, France

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Nancy, France

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Nîmes, France

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Paris, France

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Pierre-Bénite, France

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Valenciennes, France

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Vandœuvre-lès-Nancy, France

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Villejuif, France

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Berlin, Germany

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Düsseldorf, Germany

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Freiburg im Breisgau, Germany

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Mönchengladbach, Germany

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München, Germany

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Paderborn, Germany

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Trier, Germany

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Velbert, Germany

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Aviano, Italy

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Bergamo, Italy

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Genova, Italy

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Milan, Italy

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Naples, Italy

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Gdansk, Poland

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Konin, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Poznan, Poland

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Przemyśl, Poland

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Wroclaw, Poland

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Cheonan-si, South Korea

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Daegu, South Korea

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Goyang-si, South Korea

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Hwasun-eup, South Korea

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Incheon, South Korea

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Seongbuk-Gu, South Korea

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Seongnam-si, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Songpa-gu, South Korea

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Suwon, South Korea

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Badajoz, Spain

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Badalona, Spain

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Barcelona, Spain

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Burgos, Spain

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Donostia / San Sebastian, Spain

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Huelva, Spain

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Jaén, Spain

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Las Palmas de Gran Canaria, Spain

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Majadahonda, Spain

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Málaga, Spain

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Murcia, Spain

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Oviedo, Spain

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Palma de Mallorca, Spain

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Pontevedra, Spain

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Pozuelo de Alarcón, Spain

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Santander, Spain

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Toledo, Spain

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Zaragoza, Spain

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Basel, Switzerland

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Liestal, Switzerland

Research Site

Rennaz, Switzerland

View Full Details on ClinicalTrials.gov

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NCT07647328


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