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
NCT ID: NCT06380751
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2024-08-01
2030-10-18
Brief Summary
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Detailed Description
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Participants will be randomised in a 2:2:1 ratio to one of the following intervention groups:
* Arm 1: saruparib (AZD5305) plus camizestrant
* Arm 2: Physician's choice CDK4/6i plus physician's choice ET
* Arm 3: Physician's choice CDK4/6i plus camizestrant Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: saruparib (AZD5305) plus camizestrant
participants will receive saruparib (AZD5305) orally and camizestrant orally
Saruparib (AZD5305)
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
Camizestrant
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
agents are indicated below and should follow local guidelines:
* Physician's Choice CDK4/6i:
* abemaciclib orally, or
* ribociclib orally, or
* palbociclib orally.
* Physician's Choice ET:
* fulvestrant intramuscularly, or
* One of the following AIs:
* letrozole orally, or
* anastrozole orally, or
* exemestane orally
Abemaciclib
CDK4/6 Inhibitor
Ribociclib
CDK4/6 Inhibitor
Palbociclib
CDK 4/6 Inhibitor
Fulvestrant
Endocrine Therapy
Letrozole
Endorcine Therapy
Anastrozole
Endocrine Therapy
Exemestane
Endocrine Therapy
Arm 3: Physician's choice CDK4/6i plus camizestrant
participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines
Camizestrant
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
Abemaciclib
CDK4/6 Inhibitor
Ribociclib
CDK4/6 Inhibitor
Palbociclib
CDK 4/6 Inhibitor
Interventions
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Saruparib (AZD5305)
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
Camizestrant
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
Abemaciclib
CDK4/6 Inhibitor
Ribociclib
CDK4/6 Inhibitor
Palbociclib
CDK 4/6 Inhibitor
Fulvestrant
Endocrine Therapy
Letrozole
Endorcine Therapy
Anastrozole
Endocrine Therapy
Exemestane
Endocrine Therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
* Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease
* ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
* FFPE tumour tissue from each participant
* Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2
* Adequate organ and marrow function
Exclusion Criteria
* Participants with any known predisposition to bleeding
* Any history of persisting severe cytopenia
* Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
* Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection
* History of another primary malignancy
* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia
* Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease
* Evidence of active and uncontrolled hepatitis B and/or hepatitis C
* Evidence of active and uncontrolled HIV infection
* Active tuberculosis infection
* Cardiac criteria, including history of arrythmia and cardiovascular disease
* Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
* Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment
* Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET up to 28 days before randomisation
* Prior treatment within 28 days with blood product support or growth factor support
* Any systemic concurrent anti-cancer treatment
* Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:
1. Strong and moderate CYP3A4 inducers/inhibitors
2. Sensitive CYP2B6 substrates
3. Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.
* Concomitant use of drugs that are known to prolong QT and have a known risk of TdP
* Systemic use of atropine
1. Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
2. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
3. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
4. Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Gilbert, Arizona, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Aurora, Colorado, United States
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Grand Junction, Colorado, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Park Ridge, Illinois, United States
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Urbana, Illinois, United States
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Winfield, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Silver Spring, Maryland, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Dearborn, Michigan, United States
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Detroit, Michigan, United States
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Royal Oak, Michigan, United States
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Royal Oak, Michigan, United States
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Rochester, Minnesota, United States
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Springfield, Missouri, United States
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Camden, New Jersey, United States
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New Brunswick, New Jersey, United States
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Brooklyn, New York, United States
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Mineola, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Shirley, New York, United States
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Stony Brook, New York, United States
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The Bronx, New York, United States
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Westbury, New York, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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West Columbia, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Norfolk, Virginia, United States
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Tacoma, Washington, United States
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Morgantown, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Ciudad Autónoma Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Rosario, , Argentina
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Salta, , Argentina
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San Miguel de Tucumán, , Argentina
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Darlinghurst, , Australia
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Darlinghurst, , Australia
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Malvern, , Australia
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Melbourne, , Australia
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Cachoeira de Itapemirim, , Brazil
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Curitiba, , Brazil
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Fortaleza, , Brazil
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Goiânia, , Brazil
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Jaú, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Vratsa, , Bulgaria
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Toronto, , Canada
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Providencia, , Chile
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Recoleta, , Chile
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Santiago, , Chile
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Talca, , Chile
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Viña del Mar, , Chile
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Beijing, , China
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Bengbu, , China
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Changchun, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Chongqing, , China
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Foshan, , China
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Fuzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Hohhot, , China
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Jining, , China
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Kunming, , China
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Liuchow, , China
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Luoyang, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Shandong, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shijiazhuang, , China
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Tianjin, , China
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Weifang, , China
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Wuhan, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Xi'an, , China
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Xiamen, , China
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Xiangfan, , China
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Xinxiang, , China
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Zhengzhou, , China
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Brno, , Czechia
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Hořovice, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Angers, , France
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Besançon, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Paris, , France
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Rouen, , France
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Saint-Herblain, , France
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Toulouse, , France
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Villejuif, , France
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Aachen, , Germany
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Augsburg, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Dessau, , Germany
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Düsseldorf, , Germany
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Erlangen, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Ludwigsburg, , Germany
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München, , Germany
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Münster, , Germany
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Miskolc, , Hungary
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Zalaegerszeg, , Hungary
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Delhi, , India
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Kolkata, , India
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Lucknow, , India
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Mumbai, , India
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Mumbai, , India
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Mysuru, , India
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Nagpur, , India
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Nashik, , India
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New Delhi, , India
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Surat, , India
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Thiruvananthapuram, , India
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Jerusalem, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Bergamo, , Italy
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Bologna, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Padua, , Italy
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Reggio Emilia, , Italy
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Rome, , Italy
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Rozzano, , Italy
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Chiba, , Japan
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Hidaka-shi, , Japan
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Hirakata-shi, , Japan
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Isehara-shi, , Japan
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Kagoshima, , Japan
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Kashiwa, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Ota-shi, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinagawa-ku, , Japan
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Suita-shi, , Japan
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Sunto-gun, , Japan
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Takasaki-shi, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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Bandar Puncak Alam, , Malaysia
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Johor Bahru, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Selangor, , Malaysia
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Malacca, , Malaysia
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Bellavista, , Peru
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Jesus Maria, Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Biała Podlaska, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Matosinhos Municipality, , Portugal
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Porto, , Portugal
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Vila Real, , Portugal
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San Juan, , Puerto Rico
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Daegu, , 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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Barcelona, , Spain
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Cáceres, , Spain
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Granada, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Pamplona, , Spain
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Seville, , Spain
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Valencia, , Spain
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Dusit, , Thailand
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Hat Yai, , Thailand
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Ratchathewi, , Thailand
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Ratchathewi, , Thailand
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Adapazarı, , Turkey (Türkiye)
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Altındağ-Ankara, , Turkey (Türkiye)
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Çankaya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Cambridge, , United Kingdom
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Guildford, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Oxford, , United Kingdom
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Swansea, , United Kingdom
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Taunton, , United Kingdom
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Truro, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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D9722C00001
Identifier Type: -
Identifier Source: org_study_id
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