Tests saruparib with hormone therapy in advanced breast cancer with inherited gene changes
Tests saruparib with hormone therapy in adults with BRCA or PALB2 breast cancer.
Plain-language title generated from the registry record
Registry title: Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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
Key facts
- Where
- Chiba, Hidaka-shi, Hirakata-shi, Isehara-shi, Kagoshima, Kashiwa, Kōtoku, Kumamoto, Kyoto, Matsuyama, Nagoya, Osaka, Ota-shi, Sapporo, Sendai, Shinagawa-ku, Suita-shi, Sunto-gun, Takasaki-shi, Tsu, and Yokohama, JapanSee the 21 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What did the tests on your tumour show about hormone receptors and the HER2 protein?
- Have you had chemotherapy for cancer that has spread or is advanced?
Source: NCT06380751, who can take part
Where in Japan
- ChibaChiba, JapanTaking people
- Hidaka-shiHidaka-shi, JapanTaking people
- Hirakata-shiHirakata-shi, JapanTaking people
- Isehara-shiIsehara-shi, JapanTaking people
- KagoshimaKagoshima, JapanTaking people
- KashiwaKashiwa, JapanTaking people
- KōtokuKōtoku, JapanTaking people
- KumamotoKumamoto, JapanTaking people
- KyotoKyoto, JapanTaking people
- MatsuyamaMatsuyama, JapanTaking people
- NagoyaNagoya, JapanTaking people
- OsakaOsaka, JapanTaking people
- Ota-shiOta-shi, JapanTaking people
- SapporoSapporo, JapanTaking people
- SendaiSendai, JapanTaking people
- Shinagawa-kuShinagawa-ku, JapanTaking people
- Suita-shiSuita-shi, JapanTaking people
- Sunto-gunSunto-gun, JapanTaking people
- Takasaki-shiTakasaki-shi, JapanTaking people
- TsuTsu, JapanTaking people
- YokohamaYokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06380751EU 2023-504180-16-00
- Record updated
- 30 October 2026
- Original description
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 cancerRead full original descriptionShow less
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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)
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
Inclusion: 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.
Exclusion: Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection; Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia; 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 for up to 28 days total 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; The following exclusion criteria apply to treatments administered for early breast cancer:; 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; 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; History of another primary malignancy; 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; Concomitant use of drugs that are known to prolong QT and have a known risk of TdP; Systemic use of atropine.