ClinicaliQ Trial Snapshot
- Saruparib (AZD5305) Plus Camizestrant 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 — Recruiting • Phase III • Oncology • NCT06380751.
- What is being tested: Saruparib (a PARP inhibitor) combined with camizestrant (an estrogen receptor degrader) versus standard CDK4/6 inhibitor plus endocrine therapy in patients with homologous recombination repair gene mutations (BRCA1/2 or PALB2) and HR-positive, HER2-negative advanced breast cancer.
- Patient eligibility overview: Adults with advanced or metastatic HR-positive, HER2-negative breast cancer who carry pathogenic mutations in BRCA1, BRCA2, or PALB2 genes; treatment-Phase IIIïve or previously treated patients may be included depending on specific trial criteria.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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
Eligibility Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.