At a glance
ClinicalIndex Comparison Record- ✓Adult females (pre/peri/post-menopausal) and adult males
- ✓HR-positive, HER2-negative breast cancer with histologic or cytologic confirmation
- ✓Advanced disease: locally advanced not amenable to curative treatment or metastatic
- ✓ECOG performance status 0 or 1 with no deterioration over previous 2 weeks
- ✕History of MDS/AML or features suggestive of MDS/AML
- ✕Known predisposition to bleeding
- ✕History of persisting severe cytopenia
- ✕Severe or uncontrolled systemic diseases or active uncontrolled infections
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant 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)
In Brief
A Phase 3 clinical trial evaluating Saruparib (AZD5305), Camizestrant, and 7 other interventions for Advanced Breast Cancer. Currently recruiting, targeting 500 participants across 301 sites in 29 countries.
Signals
Detailed Summary
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
Study Details
Timeline
Arms & Interventions
participants will receive saruparib (AZD5305) orally and camizestrant orally
agents are indicated below and should follow local guidelines: * Physician's Choice CDK4/6i: * abemaciclib orally, or * ribociclib orally, or * palbociclib orally. * Physician's Choice ET: * fulvestrant intramuscularly, or * One of the following AIs: * letrozole orally, or * anastrozole orally, or * exemestane orally
participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines
Interventions
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
CDK4/6 Inhibitor
CDK4/6 Inhibitor
CDK 4/6 Inhibitor
Endocrine Therapy
Endorcine Therapy
Endocrine Therapy
Endocrine Therapy