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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Saruparib (AZD5305)
  • Camizestrant
  • Abemaciclib
  • Ribociclib
  • Palbociclib
  • Fulvestrant
  • Letrozole
  • Anastrozole
  • Exemestane

Treatment groups

500 Participants
are divided into 3 treatment groups

Sponsors and collaborators