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Clinical Trials in the UK / NCT06380751
Recruiting Phase 3

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

NCT06380751 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-08-01
Last updated
2026-09-02

Condition(s) studied

Advanced Breast Cancer

Investigational drug(s) / intervention(s)

Saruparib (AZD5305)CamizestrantAbemaciclibRibociclibPalbociclibFulvestrantLetrozoleAnastrozoleExemestane

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (306)

FacilityCityRegionStatus
Research Site Gilbert Arizona Recruiting
Research Site Fountain Valley California Recruiting
Research Site Glendale California Recruiting
Research Site Los Angeles California Recruiting
Research Site Newport Beach California Recruiting
Research Site Aurora Colorado Recruiting
Research Site Grand Junction Colorado Withdrawn
Research Site Hollywood Florida Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Orlando Florida Withdrawn
Research Site Orlando Florida Not Yet Recruiting
Research Site Arlington Heights Illinois Recruiting
Research Site Chicago Illinois Recruiting
Research Site Evanston Illinois Recruiting
Research Site Park Ridge Illinois Withdrawn
Research Site Schaumburg Illinois Not Yet Recruiting
Research Site Urbana Illinois Recruiting
Research Site Winfield Illinois Recruiting
Research Site Indianapolis Indiana Withdrawn
Research Site Louisville Kentucky Withdrawn
Research Site Baltimore Maryland Not Yet Recruiting
Research Site Silver Spring Maryland Withdrawn
Research Site Silver Spring Maryland Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Dearborn Michigan Withdrawn
Research Site Detroit Michigan Withdrawn
Research Site Royal Oak Michigan Withdrawn
Research Site Royal Oak Michigan Recruiting
Research Site Rochester Minnesota Recruiting
Research Site Saint Joseph Missouri Recruiting
Research Site Springfield Missouri Recruiting
Research Site St Louis Missouri Not Yet Recruiting
Research Site Camden New Jersey Recruiting
Research Site New Brunswick New Jersey Withdrawn
Research Site Brooklyn New York Withdrawn
Research Site Mineola New York Recruiting
Research Site New Hyde Park New York Withdrawn
Research Site New York New York Recruiting
Research Site New York New York Withdrawn
Research Site New York New York Recruiting

+ 266 more sites — see the full list on the official registry below.

On this site

📄 Verzenio (abemaciclib) drug profile → 📄 Kisqali (ribociclib) drug profile → 📄 Ibrance (palbociclib) drug profile →

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06380751 on ClinicalTrials.gov ↗ ← All trials in the UK