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RECRUITING

NCT06380751

PHASE3

Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

Official title: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

788

Start Date

2024-08-01

Completion Date

2031-12-30

Last Updated

2026-10-30

Healthy Volunteers

Conditions

Advanced Breast Cancer

Interventions

DRUG

Saruparib (AZD5305)

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

DRUG

Camizestrant

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

DRUG

Abemaciclib

CDK4/6 Inhibitor

DRUG

Ribociclib

CDK4/6 Inhibitor

DRUG

Palbociclib

CDK 4/6 Inhibitor

DRUG

Fulvestrant

Endocrine Therapy

DRUG

Letrozole

Endorcine Therapy

DRUG

Anastrozole

Endocrine Therapy

DRUG

Exemestane

Endocrine Therapy

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET for up to 28 days total 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 * The following exclusion criteria apply to treatments administered for early breast cancer: 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.

Locations (306)

Research Site

Gilbert, Arizona, United States

Research Site

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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Orlando, Florida, United States

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Arlington Heights, Illinois, 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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Schaumburg, 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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Baltimore, Maryland, 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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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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Saint Joseph, Missouri, United States

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Springfield, Missouri, United States

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St Louis, 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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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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San Antonio, Texas, United States

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Midlothian, Virginia, 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

Research Site

Santiago, Chile

And 206 more locations on ClinicalTrials.gov

Clinical Research Directory

Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (306)