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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (8 UK sites)
Research Site
Cambridge CB2 2QQ, United Kingdom
Research Site
Guildford GU2 7XX, United Kingdom
Research Site
London SE1 9RT, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Oxford OX3 7LE, United Kingdom
Research Site
Swansea SA2 8QA, United Kingdom
Research Site
Taunton TA1 5DA, United Kingdom
Research Site
Truro TR1 3LJ, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
