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

Recruiting now · Phase 3

Conditions studied: Advanced Breast Cancer

In brief

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

Key facts

Study ID: NCT06380751
Run by: AstraZeneca
People needed: 788
Starts: 2024-08-01
Expected to finish: 2031-12-30
Last updated by the study team: 2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
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:
Strong and moderate CYP3A4 inducers/inhibitors
Sensitive CYP2B6 substrates
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:

Where it is running

Research Site — Mineola, New York, United States (enrolling)
Research Site — Stony Brook, New York, United States (enrolling)
Research Site — Saint Joseph, Missouri, United States (enrolling)
Research Site — Camden, New Jersey, United States (enrolling)
Research Site — New York, New York, United States (enrolling)
Research Site — Gilbert, Arizona, United States (enrolling)
Research Site — Los Angeles, California, United States (enrolling)
Research Site — Rochester, Minnesota, United States (enrolling)
Research Site — Fountain Valley, California, United States (enrolling)
Research Site — Springfield, Missouri, United States (enrolling)
Research Site — New York, New York, United States (enrolling)
Research Site — Evanston, Illinois, United States (enrolling)
Research Site — Glendale, California, United States (enrolling)
Research Site — Urbana, Illinois, United States (enrolling)
Research Site — Winfield, Illinois, United States (enrolling)
Research Site — Hollywood, Florida, United States (enrolling)
Research Site — Jacksonville, Florida, United States (enrolling)
Research Site — Royal Oak, Michigan, United States (enrolling)
Research Site — Newport Beach, California, United States (enrolling)
Research Site — Silver Spring, Maryland, United States (enrolling)
Research Site — Boston, Massachusetts, United States (enrolling)
Research Site — Arlington Heights, Illinois, United States (enrolling)
Research Site — Chicago, Illinois, United States (enrolling)
Research Site — Aurora, Colorado, United States (enrolling)
Research Site — Hershey, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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