A Phase 3 Study of Saruparib (AZD5305) Plus Camizestrant in People With Metastatic Breast Cancer

In the U.S.

Full Title

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)

Purpose

In people born with certain genetic mutations or whose tumors have these mutations, the standard treatment for breast cancer with CDK4/6 inhibitors (like palbociclib, ribociclib, or abemaciclib) might not be as effective. However, their tumors may still respond to a different type of drug called PARP inhibitors.

In this study, researchers aim to learn if treatment with saruparib (a PARP1 inhibitor) and camizestrant (a new hormonal therapy) works better than standard treatments for advanced breast cancer. The people in this study have newly diagnosed metastatic (advanced) hormone receptor-positive HER2-negative breast cancer. They have either a germline (inherited) mutation in their BRCA1, BRCA2, or PALB2 genes or have a tumor with a mutation in these genes.

If you join this study, you will be randomly assigned to get one of these treatments:

Saruparib plus camizestrant
Your doctor’s choice of CDK4/6 inhibitor plus hormonal therapy (standard of care)
Your doctor’s choice of CDK4/6 inhibitor plus camizestrant