Last updated 19 days ago
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
788 patients around the world
Available in Brazil, Argentina
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.
AstraZeneca
6Research sites
788Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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 up to 28 days 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.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.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.
Sites
Organización Médica de Investigación (OMI)
Recruiting
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Universidad Católica de Salta
Recruiting
StudyEvoPAR-BR01
SponsorAstraZeneca
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06380751
