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

A vizsgálat adatai

Ki végzi

AstraZeneca

Azonosító

NCT06380751EU 2023-504180-16-00

A regiszteradat frissítve

2026. október 30.

Eredeti leírás

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 cancerA teljes eredeti leírásKevesebb

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

Bevonási feltételek: 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.

Kizáró feltételek: 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.

ClinicalTrials.gov NCT06380751 · EU CTIS 2023-504180-16-00