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Looking for participantsPhase3

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

NCT ID: NCT06380751

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Saruparib (AZD5305) (drug), Camizestrant (drug), Abemaciclib (drug), Ribociclib (drug)
How long the study runs
Study runs about 88 months (dates as stated)
About the drug or intervention
Saruparib (AZD5305) — drug: Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2. · 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 . · Abemaciclib — drug: CDK4/6 Inhibitor · Ribociclib — drug: CDK4/6 Inhibitor · Palbociclib — drug: CDK 4/6 Inhibitor · Fulvestrant — drug: Endocrine Therapy · Letrozole — drug: Endorcine Therapy · Anastrozole — drug: Endocrine Therapy · Exemestane — drug: Endocrine Therapy
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at adults with advanced breast cancer that is hormone receptor (HR)-positive, HER2-negative, and linked to an inherited change (mutation) in the BRCA1, BRCA2, or PALB2 genes. It compares a new drug called saruparib (also known as AZD5305), given either with camizestrant or with standard endocrine (hormone) therapy, against other common combinations involving a CDK4/6 inhibitor. The sponsor is AstraZeneca.

Who can take part

  • Adult men and women, including women before or after the menopause
  • Diagnosed with HR-positive, HER2-negative breast cancer confirmed by tissue tests
  • Advanced breast cancer that cannot be cured with treatment, or cancer that has spread
  • Able to carry out light activity or rest (performance status 0 or 1), with no worsening in the past 2 weeks
  • Able to provide a tumour tissue sample
  • A documented inherited mutation in BRCA1, BRCA2, or PALB2
  • Healthy enough organs and bone marrow, based on blood and other tests

Who may not be able to

  • Past or suspected blood conditions such as MDS or AML
  • Known bleeding problems
  • Long-lasting severe low blood counts
  • Severe uncontrolled illness or active uncontrolled infections
  • Ongoing sickness, gut problems, trouble swallowing tablets, or major bowel surgery in the past
  • History of another cancer
  • Ongoing moderate or worse side effects from earlier cancer treatment (hair loss not counted)
  • Cancer spread to the brain, spinal cord, or the linings around the brain
  • Uncontrolled hepatitis B or C, uncontrolled HIV, or active tuberculosis
  • Certain heart problems, including irregular heartbeat and heart disease
  • Taking hormone treatments for non-cancer reasons
  • Major surgery or serious injury in the past 4 weeks, or surgery planned during the study
  • Recent radiotherapy (within 2 weeks for a small area, or 4 weeks for a larger area)
  • Already had treatment for advanced or spread breast cancer, except up to 28 days of hormone therapy
  • Blood products or growth factors within the past 28 days
  • Any other cancer treatment at the same time
  • Certain medicines or herbal supplements within the past 21 days, including some that affect how the body processes drugs (for example warfarin and phenytoin)
  • Drugs known to affect heart rhythm
  • Systemic atropine
  • For earlier breast cancer treatment: cancer came back within 84 days of chemotherapy, within 1 year of a PARP inhibitor or platinum drug, within 1 year of a CDK4/6 inhibitor, or within 1 year of an oral SERD such as camizestrant

What taking part involves

  • • Taking saruparib (AZD5305) with camizestrant, or with endocrine (hormone) therapy
  • • Or being given a CDK4/6 inhibitor with endocrine therapy or with camizestrant, to compare

Time commitment: Not stated — ask the trial team about how long the study lasts, how many hospital visits are needed, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
788
Started
2024-08-01
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced breast cancer
  • • Phase3 - 788 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with advanced breast cancer

Where?

  • • Cambridge - Research Site
  • • Guildford - Research Site
  • • London - Research Site
  • • Manchester - Research Site
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

Approximately 4680 participants will be screened to achieve approximately 788 participants randomised to study intervention. Participants will be randomised in a 2:2:1:2 ratio to one of the following intervention groups: * Arm 1: saruparib (AZD5305) plus camizestrant * Arm 2: Physician's choice CDK4/6i plus physician's choice ET * Arm 3: Physician's choice CDK4/6i plus camizestrant * Arm 4: Saruparib (AZD5305) plus physician's choice ET Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.

Advanced Breast Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

HER2BRCA1BRCA2

What the study is looking for

  • ✓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 that has grown locally disease not amenable to curative treatment or that has spread disease
  • ✓Fit enough for normal activity (ECOG 0) or 1 with no deterioration over the previous 2 weeks
  • ✓FFPE tumour tissue from each participant

Who cannot take part

  • ✗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...
See the full criteria
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.

Where Is This Study? (8 UK sites)

Research Site

Cambridge CB2 2QQ, United Kingdom

Recruiting

Research Site

Guildford GU2 7XX, United Kingdom

Recruiting

Research Site

London SE1 9RT, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

Research Site

Oxford OX3 7LE, United Kingdom

WITHDRAWN

Research Site

Swansea SA2 8QA, United Kingdom

WITHDRAWN

Research Site

Taunton TA1 5DA, United Kingdom

Recruiting

Research Site

Truro TR1 3LJ, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08