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

NCT06380751 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: D9722C00001
• Study Type: interventional
• Target: 500
• Locations: 28 countries
• Sites: 294

Brief Summary

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

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.

  Up to approximately 59 months

Secondary Outcomes (11)

• Overall Survival

  Up to approximately 88 months

• Progression Free Survival 2

  Up to approximately 59 months

• Time to chemotherapy

  Up to approximately 59 months

• Objective Response Rate

  Up to approximately 59 months

• Duration of Response

  Up to approximately 59 months

Study Arms (3)

Arm 1: saruparib (AZD5305) plus camizestrant

EXPERIMENTAL

participants will receive saruparib (AZD5305) orally and camizestrant orally

Drug: Saruparib (AZD5305); Drug: Camizestrant

Arm 2: Physician's choice CDK4/6i plus physician's choice ET

ACTIVE COMPARATOR

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

Drug: Abemaciclib; Drug: Ribociclib; Drug: Palbociclib; Drug: Fulvestrant; Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane

Arm 3: Physician's choice CDK4/6i plus camizestrant

EXPERIMENTAL

participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines

Drug: Camizestrant; Drug: Abemaciclib; Drug: Ribociclib; Drug: Palbociclib

Interventions

Saruparib (AZD5305) DRUG

Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.

Arm 1: saruparib (AZD5305) plus camizestrant

Camizestrant DRUG

Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .

Arm 1: saruparib (AZD5305) plus camizestrant; Arm 3: Physician's choice CDK4/6i plus camizestrant

Abemaciclib DRUG

CDK4/6 Inhibitor

Arm 2: Physician's choice CDK4/6i plus physician's choice ET; Arm 3: Physician's choice CDK4/6i plus camizestrant

Ribociclib DRUG

CDK4/6 Inhibitor

Arm 2: Physician's choice CDK4/6i plus physician's choice ET; Arm 3: Physician's choice CDK4/6i plus camizestrant

Palbociclib DRUG

CDK 4/6 Inhibitor

Arm 2: Physician's choice CDK4/6i plus physician's choice ET; Arm 3: Physician's choice CDK4/6i plus camizestrant

Fulvestrant DRUG

Endocrine Therapy

Arm 2: Physician's choice CDK4/6i plus physician's choice ET

Letrozole DRUG

Endorcine Therapy

Arm 2: Physician's choice CDK4/6i plus physician's choice ET

Anastrozole DRUG

Endocrine Therapy

Arm 2: Physician's choice CDK4/6i plus physician's choice ET

Exemestane DRUG

Endocrine Therapy

Arm 2: Physician's choice CDK4/6i plus physician's choice ET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
• 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

You may not qualify if:

• Participants with history of MDS/AML or with features suggestive of MDS/AML
• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (298)

Research Site

Gilbert, Arizona, 85234, United States

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Fountain Valley, California, 92708, United States

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Glendale, California, 91206, United States

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Los Angeles, California, 90089, United States

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Newport Beach, California, 92663, United States

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Aurora, Colorado, 80045, United States

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Grand Junction, Colorado, 81501, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32224, United States

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Orlando, Florida, 32806, United States

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Chicago, Illinois, 60611, United States

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Evanston, Illinois, 60201, United States

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Park Ridge, Illinois, 60068, United States

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Urbana, Illinois, 61801, United States

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Winfield, Illinois, 60190, United States

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Indianapolis, Indiana, 46227, United States

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Louisville, Kentucky, 40207, United States

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Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

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Silver Spring, Maryland, 20902, United States

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Silver Spring, Maryland, 20904, United States

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Boston, Massachusetts, 02215, United States

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Dearborn, Michigan, 48126, United States

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Detroit, Michigan, 48202, United States

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Royal Oak, Michigan, 48073, United States

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Royal Oak, Michigan, 48073, United States

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Rochester, Minnesota, 55905, United States

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Springfield, Missouri, 65804, United States

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St Louis, Missouri, 63110, United States

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Camden, New Jersey, 08103, United States

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New Brunswick, New Jersey, 08901, United States

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Brooklyn, New York, 11220, United States

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Mineola, New York, 11501, United States

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New Hyde Park, New York, 11042, United States

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New York, New York, 10016, United States

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New York, New York, 10028, United States

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New York, New York, 10065, United States

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Shirley, New York, 11967, United States

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Stony Brook, New York, 11790, United States

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The Bronx, New York, 10469, United States

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Westbury, New York, 11590, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15215, United States

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West Columbia, South Carolina, 29169, United States

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Chattanooga, Tennessee, 37404, United States

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Nashville, Tennessee, 37203, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77054, 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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Morgantown, West Virginia, 26506, United States

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Milwaukee, Wisconsin, 53215, United States

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Ciudad Autónoma Buenos Aires, 1125, Argentina

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Ciudad de Buenos Aires, 1015, Argentina

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Ciudad de Buenos Aires, C1280AEB, Argentina

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Córdoba, 5008, Argentina

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Rosario, S2000KZE, Argentina

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Salta, A4400EMI, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Darlinghurst, 2010, Australia

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Darlinghurst, 2139, Australia

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Malvern, 3144, Australia

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Melbourne, VIC 3000, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Linz, 4010, Austria

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Vienna, 1090, Austria

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Cachoeira de Itapemirim, 29308-055, Brazil

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Curitiba, 80060-900, Brazil

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Fortaleza, 60336-045, Brazil

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Goiânia, 74000-000, Brazil

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Jaú, 17210-120, Brazil

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Porto Alegre, 91350-200, Brazil

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Ribeirão Preto, 14049-901, Brazil

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Salvador, 41253-190, Brazil

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São Paulo, 01509-900, Brazil

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São Paulo, 03102-002, Brazil

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Plovdiv, 4002, Bulgaria

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Sofia, 1527, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Vratsa, 3000, Bulgaria

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Toronto, Ontario, M5G 2M9, Canada

NOT YET RECRUITING

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Greenfield Park, Quebec, J4V 2G9, Canada

NOT YET RECRUITING

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Montreal, Quebec, H2X 0A9, Canada

NOT YET RECRUITING

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Montreal, Quebec, H3T 1E2, Canada

NOT YET RECRUITING

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Montreal, Quebec, H4A 3J1, Canada

NOT YET RECRUITING

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Saskatoon, Saskatchewan, S7N 4H4, Canada

NOT YET RECRUITING

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Toronto, M4N 3M5, Canada

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Providencia, 7500994, Chile

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Recoleta, 8420391, Chile

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Santiago, 8330034, Chile

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Talca, 3461341, Chile

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Viña del Mar, 2520000, Chile

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Beijing, 100044, China

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Bengbu, 233004, China

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Changchun, 130012, China

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Changchun, 130021, China

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Changsha, 410008, China

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Changsha, 410013, China

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Chengdu, 610000, China

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Chengdu, 610072, China

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Chongqing, 400042, China

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Foshan, 528000, China

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Fuzhou, 350014, China

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Guangzhou, 510060, China

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Guangzhou, 510062, China

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Guangzhou, 510289, China

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Hangzhou, 310016, China

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Hangzhou, 310022, China

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Harbin, 150081, China

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Hefei, 230031, China

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Hohhot, 010017, China

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Jining, 272029, China

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Kunming, 650118, China

NOT YET RECRUITING

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Liuzhou, 545006, China

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Luoyang, 471000, China

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Nanchang, 330006, China

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Nanchang, 330009, China

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Nanjing, 210029, China

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Shandong, 250117, China

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Shanghai, 200025, China

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Shanghai, 200120, China

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Shenyang, 110016, China

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Shijiazhuang, 050000, China

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Tianjin, 300000, China

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Weifang, 261000, China

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Wuhan, 430030, China

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Wuhan, 430040, China

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Wuhan, 430079, China

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Xi'an, 710006, China

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Xi'an, 710061, China

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Xiamen, 361003, China

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Xiangyang, 441000, China

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Xinxiang, 453100, China

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Zhengzhou, 450008, China

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Brno, 656 53, Czechia

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Hořovice, 26831, Czechia

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Hradec Králové, 500 05, Czechia

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Olomouc, 77900, Czechia

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Prague, 120 00, Czechia

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Prague, 180 00, Czechia

NOT YET RECRUITING

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Angers, 49100, France

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Besançon, 25030, France

SUSPENDED

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Lille, 59000, France

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Lyon, 69373, France

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Marseille, 13273, France

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Paris, 75005, France

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Rouen, 76021, France

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Saint-Herblain, 44805, France

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Toulouse, 31059, France

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Villejuif, 94805, France

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Aachen, 52074, Germany

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Augsburg, 86150, Germany

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Berlin, 13125, Germany

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Cologne, 50937, Germany

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Dessau, 06847, Germany

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Düsseldorf, 40225, Germany

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Erlangen, 91054, Germany

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Göttingen, DE-37099, Germany

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Hamburg, 20357, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Kiel, 24105, Germany

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Leipzig, 04103, Germany

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Ludwigsburg, 71640, Germany

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München, 81675, Germany

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Münster, 48149, Germany

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Hong Kong, 150001, Hong Kong

NOT YET RECRUITING

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Hong Kong, 999077, Hong Kong

NOT YET RECRUITING

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Budapest, 1082, Hungary

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Budapest, 1122, Hungary

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Budapest, 1145, Hungary

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Debrecen, 4032, Hungary

NOT YET RECRUITING

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Miskolc, 3526, Hungary

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Zalaegerszeg, 8900, Hungary

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Delhi, 110029, India

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Kolkata, 700160, India

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Lucknow, 226003, India

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Mumbai, 400012, India

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Mumbai, 400052, India

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Mysuru, 570017, India

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Nagpur, 440001, India

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Nashik, 422002, India

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New Delhi, 110085, India

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Surat, 396007, India

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Thiruvananthapuram, 695011, India

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Jerusalem, 9103102, Israel

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Jerusalem, 9112001, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Tel Aviv, 64239, Israel

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Bergamo, 24127, Italy

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Bologna, 40138, Italy

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Milan, 20132, Italy

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Milan, 20141, Italy

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Modena, 41124, Italy

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Naples, 80131, Italy

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Padova, 35128, Italy

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Reggio Emilia, 422122, Italy

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Rome, 00168, Italy

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Rozzano, 20089, Italy

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Chiba, 260-8717, Japan

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Hidaka-shi, 350-1298, Japan

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Hirakata-shi, 573-1191, Japan

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Isehara-shi, 259-1193, Japan

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Kagoshima, 892-0833, Japan

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Kashiwa, 227-8577, Japan

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Kōtoku, 135-8550, Japan

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Kumamoto, 860-8556, Japan

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Kyoto, 606-8507, Japan

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Matsuyama, 791-0280, Japan

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Nagoya, 464-8681, Japan

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Nagoya, 466-8560, Japan

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Nagoya, 467-8602, Japan

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Osaka, 541-8567, Japan

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Ota-shi, 373-8550, Japan

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Sapporo, 003-0804, Japan

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Sendai, 980-8574, Japan

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Shinagawa-ku, 142-8666, Japan

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Suita-shi, 565-0871, Japan

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Sunto-gun, 411-8777, Japan

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Takasaki-shi, 370-0829, Japan

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Tsu, 514-8507, Japan

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Yokohama, 241-8515, Japan

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Bandar Puncak Alam, 42300, Malaysia

NOT YET RECRUITING

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Johor Bahru, 81100, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Kuala Selangor, 62250, Malaysia

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Malacca, 75000, Malaysia

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Bellavista, CALLAO 2, Peru

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Jesus Maria, Lima, LIMA 11, Peru

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Lima, 15036, Peru

NOT YET RECRUITING

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Lima, LIMA 29, Peru

NOT YET RECRUITING

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Biała Podlaska, 21-500, Poland

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Koszalin, 75-581, Poland

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Lodz, 93-338, Poland

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Lublin, 20-090, Poland

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Poznan, 60-569, Poland

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Poznan, 61-485, Poland

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Radom, 26-600, Poland

NOT YET RECRUITING

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Warsaw, 02-781, Poland

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Coimbra, 3000-075, Portugal

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Lisbon, 1099-023, Portugal

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Lisbon, 1998-018, Portugal

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Matosinhos Municipality, 4454-509, Portugal

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Porto, 4050-115, Portugal

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Vila Real, 5000-508, Portugal

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San Juan, 00918, Puerto Rico

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Daegu, 41404, South Korea

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Seongnam-si, 13620, South Korea

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Seoul, 02841, South Korea

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Seoul, 03080, South Korea

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Seoul, 06273, South Korea

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Seoul, 06351, South Korea

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Seoul, 3722, South Korea

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Seoul, 5505, South Korea

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A Coruña, 15009, Spain

NOT YET RECRUITING

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Barcelona, 08035, Spain

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Cáceres, 10003, Spain

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Granada, 18007, Spain

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L'Hospitalet de Llobregat, 08908, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Málaga, 29010, Spain

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Pamplona, 31008, Spain

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Seville, 41013, Spain

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Valencia, 46006, Spain

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Zaragoza, 50009, Spain

NOT YET RECRUITING

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New Taipei City, 23561, Taiwan

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Taichung, Taiwan

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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Taipei, 10449, Taiwan

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Taipei, 112, Taiwan

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Taoyuan, 00333, Taiwan

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Bangkok, 10210, Thailand

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Bangkok, 10330, Thailand

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Dusit, 10300, Thailand

TERMINATED

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Hat Yai, 90110, Thailand

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Muang, 22000, Thailand

NOT YET RECRUITING

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Ratchathewi, 10400, Thailand

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Ratchathewi, 10400, Thailand

NOT YET RECRUITING

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Adapazarı, 54290, Turkey (Türkiye)

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Altındağ-Ankara, 06230, Turkey (Türkiye)

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Ankara, 06530, Turkey (Türkiye)

NOT YET RECRUITING

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Çankaya, 06680, Turkey (Türkiye)

WITHDRAWN

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Istanbul, 34214, Turkey (Türkiye)

RECRUITING

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Kayseri, 38039, Turkey (Türkiye)

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Cambridge, CB2 2QQ, United Kingdom

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Guildford, GU2 7XX, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Oxford, OX3 7LE, United Kingdom

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Swansea, SA2 8QA, United Kingdom

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Taunton, TA1 5DA, United Kingdom

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Truro, TR1 3LJ, United Kingdom

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MeSH Terms

Interventions

AZD5305; AZD9833; abemaciclib; ribociclib; palbociclib; Fulvestrant; Letrozole; Anastrozole; exemestane

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 24, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): October 18, 2030
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Locations

CN (42); ES (12); CL (5); TH (7); JP (23); AR (7); BR (10); TU (6); MY (5); KR (8); CZ (6); PR (1); US (54); IN (11); FR (10); IT (10); BU (4); HK (2); GB (8); DE (16); PT (6); IL (5); TW (7); PE (4); CA (7); HU (6); PL (8); AU (4)