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Camizestrant Compared With CDK4\u002F6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+\u002F ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer","A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4\u002F6 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+\u002F ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)","EvoPAR-BR01","Inclusion Criteria:\n\n* Adult females, pre\u002Fperi-menopausal and\u002For post-menopausal, and adult males\n* Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer\n* Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease\n* ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks\n* FFPE tumour tissue from each participant\n* Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Participants with history of MDS\u002FAML or with features suggestive of MDS\u002FAML\n* Participants with any known predisposition to bleeding\n* Any history of persisting severe cytopenia\n* Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections\n* Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection\n* History of another primary malignancy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia\n* Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease\n* Evidence of active and uncontrolled hepatitis B and\u002For hepatitis C\n* Evidence of active and uncontrolled HIV infection\n* Active tuberculosis infection\n* Cardiac criteria, including history of arrythmia and cardiovascular disease\n* Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions\n* 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\n* 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\n* Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET up to 28 days before randomisation\n* Prior treatment within 28 days with blood product support or growth factor support\n* Any systemic concurrent anti-cancer treatment\n* Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:\n\n  1. Strong and moderate CYP3A4 inducers\u002Finhibitors\n  2. Sensitive CYP2B6 substrates\n  3. Substrates of CYP2C9 and\u002For CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.\n* Concomitant use of drugs that are known to prolong QT and have a known risk of TdP\n* Systemic use of atropine\n* The following exclusion criteria apply to treatments administered for early breast cancer:\n\n  1. Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy\n  2. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and\u002For platinum agent for early breast cancer\n  3. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4\u002F6i in the adjuvant setting\n  4. Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.","ALL","18 Years",{"count":2334,"type":2335},500,"ESTIMATED","INTERVENTIONAL",[2338],"PHASE3","The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4\u002F6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+\u002F ISH non-amplified) advanced breast cancer",[2341],"Advanced Breast Cancer","2026-06-26",{"date":2344,"type":2345},"2026-06-29","ACTUAL",{"date":2347,"type":2345},"2024-08-01",{"date":2349,"type":2335},"2030-10-18",{"name":5,"class":6},301]