RecruitingPhase 3

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

United States500 participantsStarted 2024-08-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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.
✕. Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
✕. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
✕. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
✕. Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.

What they're measuring

Progression-Free Survival

Timeframe: Up to approximately 59 months

Trial details

NCT IDNCT06380751

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-03-30

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

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