RecruitingPhase III🇵🇱 PolandEN original

Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Dorosłe kobiety (przed, w trakcie lub po menopauzie) oraz dorośli mężczyźni
  • Potwierdzony nowotwór piersi dodatni na receptor hormonalny i ujemny na HER2
  • Zaawansowany nowotwór piersi, który nie może być wyleczony operacyjnie lub rozprzestrzeniło się na inne części ciała
  • Dobry ogólny stan zdrowia (wynik 0 lub 1 w skali ECOG bez pogorszenia w ostatnich 2 tygodniach)
  • Pobrany materiał tkankowy z guza
  • Potwierdzona mutacja genetyczna BRCA1, BRCA2 lub PALB2
  • Prawidłowe funkcjonowanie narządów i szpiku kostnego

✗ Disqualifies

  • Historia zespołu mielodysplastycznego lub białaczki
  • Склonność do krwawień
  • Historia poważnego i długotrwałego zmniejszenia liczby komórek krwi
  • Poważne choroby zakaźne lub inne niekontrolowane choroby
  • Opory niezleczone nudności i wymioty, choroby przewodu pokarmowego lub wcześniejsza duża operacja jelit
  • Historia innego nowotworu złośliwego
  • Efekty uboczne po poprzedniej chemioterapii (stopień 2 lub wyższy, z wyjątkiem wypadania włosów)
  • Uciśnięcie rdzenia kręgowego, przerzuty do mózgu lub rozprzestrzenienie się raka na opony mózgowe

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 29, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (301)

Research Site

Gilbert, United States

Research Site

Fountain Valley, United States

Research Site

Glendale, United States

Research Site

Los Angeles, United States

Research Site

Newport Beach, United States

Research Site

Aurora, United States

Research Site

Grand Junction, United States

Research Site

Hollywood, United States

Research Site

Jacksonville, United States

Research Site

Orlando, United States

Research Site

Chicago, United States

Research Site

Evanston, United States

Research Site

Park Ridge, United States

Research Site

Urbana, United States

Research Site

Winfield, United States

Research Site

Indianapolis, United States

Research Site

Louisville, United States

Research Site

Baltimore, United States

Research Site

Silver Spring, United States

Research Site

Silver Spring, United States

Research Site

Boston, United States

Research Site

Dearborn, United States

Research Site

Detroit, United States

Research Site

Royal Oak, United States

Research Site

Royal Oak, United States

Research Site

Rochester, United States

Research Site

Saint Joseph, United States

Research Site

Springfield, United States

Research Site

St Louis, United States

Research Site

Camden, United States

Research Site

New Brunswick, United States

Research Site

Brooklyn, United States

Research Site

Mineola, United States

Research Site

New Hyde Park, United States

Research Site

New York, United States

Research Site

New York, United States

Research Site

New York, United States

Research Site

Shirley, United States

Research Site

Stony Brook, United States

Research Site

The Bronx, United States

Research Site

Westbury, United States

Research Site

Hershey, United States

Research Site

Philadelphia, United States

Research Site

Pittsburgh, United States

Research Site

Pittsburgh, United States

Research Site

West Columbia, United States

Research Site

Chattanooga, United States

Research Site

Nashville, United States

Research Site

Houston, United States

Research Site

Houston, United States

Research Site

Houston, United States

Research Site

San Antonio, United States

Research Site

Norfolk, United States

Research Site

Tacoma, United States

Research Site

Morgantown, United States

Research Site

Milwaukee, United States

Research Site

Ciudad Autónoma Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Rosario, Argentina

Research Site

Salta, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

Darlinghurst, Australia

Research Site

Darlinghurst, Australia

Research Site

Malvern, Australia

Research Site

Melbourne, Australia

Research Site

Graz, Austria

Research Site

Innsbruck, Austria

Research Site

Linz, Austria

Research Site

Vienna, Austria

Research Site

Cachoeira de Itapemirim, Brazil

Research Site

Curitiba, Brazil

Research Site

Fortaleza, Brazil

Research Site

Goiânia, Brazil

Research Site

Jaú, Brazil

Research Site

Porto Alegre, Brazil

Research Site

Ribeirão Preto, Brazil

Research Site

Salvador, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

Plovdiv, Bulgaria

Research Site

Sofia, Bulgaria

Research Site

Stara Zagora, Bulgaria

Research Site

Vratsa, Bulgaria

Research Site

Toronto, Canada

Research Site

Greenfield Park, Canada

Research Site

Montreal, Canada

Research Site

Montreal, Canada

Research Site

Montreal, Canada

Research Site

Saskatoon, Canada

Research Site

Toronto, Canada

Research Site

Providencia, Chile

Research Site

Recoleta, Chile

Research Site

Santiago, Chile

Research Site

Talca, Chile

Research Site

Viña del Mar, Chile

Research Site

Beijing, China

Research Site

Bengbu, China

Research Site

Changchun, China

Research Site

Changchun, China

Research Site

Changsha, China

Research Site

Changsha, China

Research Site

Chengdu, China

Research Site

Chengdu, China

Research Site

Chongqing, China

Research Site

Foshan, China

Research Site

Fuzhou, China

Research Site

Guangzhou, China

Research Site

Guangzhou, China

Research Site

Guangzhou, China

Research Site

Hangzhou, China

Research Site

Hangzhou, China

Research Site

Harbin, China

Research Site

Hefei, China

Research Site

Hohhot, China

Research Site

Jining, China

Research Site

Kunming, China

Research Site

Liuzhou, China

Research Site

Luoyang, China

Research Site

Nanchang, China

Research Site

Nanchang, China

Research Site

Nanjing, China

Research Site

Shandong, China

Research Site

Shanghai, China

Research Site

Shanghai, China

Research Site

Shenyang, China

Research Site

Shijiazhuang, China

Research Site

Tianjin, China

Research Site

Weifang, China

Research Site

Wuhan, China

Research Site

Wuhan, China

Research Site

Wuhan, China

Research Site

Xi'an, China

Research Site

Xi'an, China

Research Site

Xiamen, China

Research Site

Xiangyang, China

Research Site

Xinxiang, China

Research Site

Zhengzhou, China

Research Site

Brno, Czechia

Research Site

Hořovice, Czechia

Research Site

Hradec Králové, Czechia

Research Site

Olomouc, Czechia

Research Site

Prague, Czechia

Research Site

Prague, Czechia

Research Site

Angers, France

Research Site

Besançon, France

Research Site

Lille, France

Research Site

Lyon, France

Research Site

Marseille, France

Research Site

Paris, France

Research Site

Rouen, France

Research Site

Saint-Herblain, France

Research Site

Toulouse, France

Research Site

Villejuif, France

Research Site

Aachen, Germany

Research Site

Augsburg, Germany

Research Site

Berlin, Germany

Research Site

Cologne, Germany

Research Site

Dessau, Germany

Research Site

Düsseldorf, Germany

Research Site

Erlangen, Germany

Research Site

Göttingen, Germany

Research Site

Hamburg, Germany

Research Site

Hanover, Germany

Research Site

Heidelberg, Germany

Research Site

Kiel, Germany

Research Site

Leipzig, Germany

Research Site

Ludwigsburg, Germany

Research Site

München, Germany

Research Site

Münster, Germany

Research Site

Hong Kong, Hong Kong

Research Site

Hong Kong, Hong Kong

Research Site

Budapest, Hungary

Research Site

Budapest, Hungary

Research Site

Budapest, Hungary

Research Site

Budapest, Hungary

Research Site

Debrecen, Hungary

Research Site

Miskolc, Hungary

Research Site

Zalaegerszeg, Hungary

Research Site

Delhi, India

Research Site

Kolkata, India

Research Site

Lucknow, India

Research Site

Mumbai, India

Research Site

Mumbai, India

Research Site

Mysuru, India

Research Site

Nagpur, India

Research Site

Nashik, India

Research Site

New Delhi, India

Research Site

Surat, India

Research Site

Thiruvananthapuram, India

Research Site

Jerusalem, Israel

Research Site

Jerusalem, Israel

Research Site

Petah Tikva, Israel

Research Site

Ramat Gan, Israel

Research Site

Tel Aviv, Israel

Research Site

Bergamo, Italy

Research Site

Bologna, Italy

Research Site

Milan, Italy

Research Site

Milan, Italy

Research Site

Modena, Italy

Research Site

Naples, Italy

Research Site

Padova, Italy

Research Site

Reggio Emilia, Italy

Research Site

Rome, Italy

Research Site

Rozzano, Italy

Research Site

Chiba, Japan

Research Site

Hidaka-shi, Japan

Research Site

Hirakata-shi, Japan

Research Site

Isehara-shi, Japan

Research Site

Kagoshima, Japan

Research Site

Kashiwa, Japan

Research Site

Kōtoku, Japan

Research Site

Kumamoto, Japan

Research Site

Kyoto, Japan

Research Site

Matsuyama, Japan

Research Site

Nagoya, Japan

Research Site

Nagoya, Japan

Research Site

Nagoya, Japan

Research Site

Osaka, Japan

Research Site

Ota-shi, Japan

Research Site

Sapporo, Japan

Research Site

Sendai, Japan

Research Site

Shinagawa-ku, Japan

Research Site

Suita-shi, Japan

Research Site

Sunto-gun, Japan

Research Site

Takasaki-shi, Japan

Research Site

Tsu, Japan

Research Site

Yokohama, Japan

Research Site

Bandar Puncak Alam, Malaysia

Research Site

Johor Bahru, Malaysia

Research Site

Kuala Lumpur, Malaysia

Research Site

Kuala Selangor, Malaysia

Research Site

Malacca, Malaysia

Research Site

Bellavista, Peru

Research Site

Jesus Maria, Lima, Peru

Research Site

Lima, Peru

Research Site

Lima, Peru

Research Site

Biała Podlaska, Poland

Research Site

Koszalin, Poland

Research Site

Lodz, Poland

Research Site

Lublin, Poland

Research Site

Poznan, Poland

Research Site

Poznan, Poland

Research Site

Radom, Poland

Research Site

Warsaw, Poland

Research Site

Coimbra, Portugal

Research Site

Lisbon, Portugal

Research Site

Lisbon, Portugal

Research Site

Matosinhos Municipality, Portugal

Research Site

Porto, Portugal

Research Site

Vila Real, Portugal

Research Site

San Juan, Puerto Rico

Research Site

Daegu, South Korea

Research Site

Seongnam-si, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

A Coruña, Spain

Research Site

Barcelona, Spain

Research Site

Cáceres, Spain

Research Site

Granada, Spain

Research Site

L'Hospitalet de Llobregat, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Málaga, Spain

Research Site

Pamplona, Spain

Research Site

Seville, Spain

Research Site

Valencia, Spain

Research Site

Zaragoza, Spain

Research Site

New Taipei City, Taiwan

Research Site

Taichung, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taoyuan, Taiwan

Research Site

Bangkok, Thailand

Research Site

Bangkok, Thailand

Research Site

Dusit, Thailand

Research Site

Hat Yai, Thailand

Research Site

Muang, Thailand

Research Site

Ratchathewi, Thailand

Research Site

Ratchathewi, Thailand

Research Site

Adapazarı, Turkey (Türkiye)

Research Site

Altındağ-Ankara, Turkey (Türkiye)

Research Site

Ankara, Turkey (Türkiye)

Research Site

Çankaya, Turkey (Türkiye)

Research Site

Istanbul, Turkey (Türkiye)

Research Site

Kayseri, Turkey (Türkiye)

Research Site

Cambridge, United Kingdom

Research Site

Guildford, United Kingdom

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Oxford, United Kingdom

Research Site

Swansea, United Kingdom

Research Site

Taunton, United Kingdom

Research Site

Truro, United Kingdom

Trial contact

AstraZeneca Clinical Study Information Center

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.