Tests saruparib with hormone therapy in advanced breast cancer with inherited gene changes
Tests saruparib with hormone therapy in adults with BRCA or PALB2 breast cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Angers, Besancon Cedex, Lille, Lyon, Marseille, Paris, Rouen, Saint-Herblain Cedex, Toulouse Cedex 9, and Villejuif Cedex, FranceSee the 10 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced breast cancer that is hormone receptor positive and HER2 negative, and who carry a BRCA1, BRCA2 or PALB2 gene mutation. It has not been treated before for advanced disease.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Breast cancer that has spread locally and cannot be cured by treatment, or has spread to other parts of the body (metastatic). HR-positive, HER2-negative. ECOG performance status of 0 or 1.
- Earlier treatment
- No earlier systemic cancer treatment for advanced or metastatic disease, except hormone therapy for up to 28 days in total before randomisation. Some treatments for early breast cancer must have ended long enough before the cancer progressed.
- Biomarker or test result
- A documented germline loss-of-function mutation in BRCA1, BRCA2 or PALB2. Tumour tissue (FFPE) must be available.
Main reasons for not taking part
- History of MDS/AML or signs of it
- Brain metastases, spinal cord compression or meningeal spread of the cancer
- Another primary cancer in the past
- Active uncontrolled infection, including hepatitis B, hepatitis C, HIV or tuberculosis
- Heart problems, including a history of arrhythmia or cardiovascular disease
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What did the tests on your tumour show about hormone receptors and the HER2 protein?
- Have you had chemotherapy for cancer that has spread or is advanced?
Source: NCT06380751, who can take part
Where in France
- Institut de Cancerologie de L'OuestAngers, FranceTaking people
- CHU BesanconBesancon Cedex, FranceTaking people
- Centre Oscar LambretLille, FranceTaking people
- Centre Leon BerardLyon, FranceTaking people
- Institut Paoli-CalmettesMarseille, FranceTaking people
- Institut CurieParis, FranceTaking people
- Centre Henri BecquerelRouen, FranceTaking people
- Institut De Cancerologie De L OuestSaint-Herblain Cedex, FranceTaking people
- Oncopole Claudius RegaudToulouse Cedex 9, FranceTaking people
- Institut Gustave RoussyVillejuif Cedex, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06380751EU 2023-504180-16-00
- Record updated
- 30 October 2026
- Original description
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 cancerRead full original descriptionShow less
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)
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
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: Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection; Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia; 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; The following exclusion criteria apply to treatments administered for early breast cancer:; Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy; Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer; Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting; Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant; 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; History of another primary malignancy; 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; Concomitant use of drugs that are known to prolong QT and have a known risk of TdP; Systemic use of atropine.