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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

+ 2 more criteria — see the full checklist in the app.

Where this trial is running

• Research Site, Gilbert, Arizona, United States
• Research Site, Fountain Valley, California, United States
• Research Site, Glendale, California, United States
• Research Site, Los Angeles, California, United States
• Research Site, Newport Beach, California, United States
• Research Site, Aurora, Colorado, United States
• Research Site, Grand Junction, Colorado, United States
• Research Site, Hollywood, Florida, United States
• Research Site, Jacksonville, Florida, United States
• Research Site, Orlando, Florida, United States
• Research Site, Chicago, Illinois, United States
• Research Site, Evanston, Illinois, United States

+ 289 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06380751.