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Saruparib and Camizestrant for Advanced Breast Cancer

This study is for adults with advanced breast cancer that is hormone receptor-positive (HR-positive) and HER2-negative, and has specific changes in the BRCA1, BRCA2, or PALB2 genes. It compares a combination of saruparib and camizestrant to standard treatments like CDK4/6 inhibitors (such as abemaciclib, ribociclib, or palbociclib) with either endocrine therapy or camizestrant. Saruparib works by blocking PARP1, and camizestrant is a type of endocrine therapy. The main goal is to see how long people live without their cancer growing (Progression-Free Survival). About 500 participants will be involved.

Study design
This is an interventional study that will randomize approximately 500 participants into three different treatment groups. Participants will be assigned to a group in a 2:2:1 ratio.
What's involved
Treatment continues until the cancer progresses, side effects are too severe, or you decide to stop. The trial record does not specify the number of visits or specific procedures.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Progression-Free Survival for up to approximately 59 months.

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NCT06380751

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
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~788 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Saruparib (AZD5305)CamizestrantAbemaciclibRibociclibPalbociclibFulvestrant

At a glance

Recruiting sites
237 of 302 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (Arm 1 vs arm 2)
Measured over Up to approximately 64 months

Conditions

Advanced Breast Cancer

Explore related trials

Breast CarcinomaBRCA1 GeneBRCA2 GenePartner and Localizer of BRCA2

Where it's being run

302 sites across 53 states
China42
Japan23
Germany16
Spain12
India11
New York10
Brazil10
France10

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
Concomitant use of drugs that are known to prolong QT and have a known risk of TdP
Systemic use of atropine

What this trial measures

  • Progression-Free Survival (Arm 1 vs arm 2)Up to approximately 64 months

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