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
Condition(s) studied
Investigational drug(s) / intervention(s)
Saruparib (AZD5305): Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
Camizestrant: Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
Abemaciclib: CDK4/6 Inhibitor
Ribociclib: CDK4/6 Inhibitor
Palbociclib: CDK 4/6 Inhibitor
Fulvestrant: Endocrine Therapy
Letrozole: Endorcine Therapy
Anastrozole: Endocrine Therapy
Exemestane: Endocrine Therapy
Study 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
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (Arm 1 vs arm 2) — Up to approximately 64 months
PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
Trial sites (306)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Gilbert | Arizona | Recruiting |
| Research Site | Fountain Valley | California | Recruiting |
| Research Site | Glendale | California | Recruiting |
| Research Site | Los Angeles | California | Recruiting |
| Research Site | Newport Beach | California | Recruiting |
| Research Site | Aurora | Colorado | Recruiting |
| Research Site | Grand Junction | Colorado | Withdrawn |
| Research Site | Hollywood | Florida | Recruiting |
| Research Site | Jacksonville | Florida | Recruiting |
| Research Site | Orlando | Florida | Withdrawn |
| Research Site | Orlando | Florida | Not Yet Recruiting |
| Research Site | Arlington Heights | Illinois | Recruiting |
| Research Site | Chicago | Illinois | Recruiting |
| Research Site | Evanston | Illinois | Recruiting |
| Research Site | Park Ridge | Illinois | Withdrawn |
| Research Site | Schaumburg | Illinois | Not Yet Recruiting |
| Research Site | Urbana | Illinois | Recruiting |
| Research Site | Winfield | Illinois | Recruiting |
| Research Site | Indianapolis | Indiana | Withdrawn |
| Research Site | Louisville | Kentucky | Withdrawn |
| Research Site | Baltimore | Maryland | Not Yet Recruiting |
| Research Site | Silver Spring | Maryland | Withdrawn |
| Research Site | Silver Spring | Maryland | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Dearborn | Michigan | Withdrawn |
| Research Site | Detroit | Michigan | Withdrawn |
| Research Site | Royal Oak | Michigan | Withdrawn |
| Research Site | Royal Oak | Michigan | Recruiting |
| Research Site | Rochester | Minnesota | Recruiting |
| Research Site | Saint Joseph | Missouri | Recruiting |
| Research Site | Springfield | Missouri | Recruiting |
| Research Site | St Louis | Missouri | Not Yet Recruiting |
| Research Site | Camden | New Jersey | Recruiting |
| Research Site | New Brunswick | New Jersey | Withdrawn |
| Research Site | Brooklyn | New York | Withdrawn |
| Research Site | Mineola | New York | Recruiting |
| Research Site | New Hyde Park | New York | Withdrawn |
| Research Site | New York | New York | Recruiting |
| Research Site | New York | New York | Withdrawn |
| Research Site | New York | New York | Recruiting |
+ 266 more sites — see the full list on the official registry below.
On this site
📄 Verzenio (abemaciclib) drug profile → 📄 Kisqali (ribociclib) drug profile → 📄 Ibrance (palbociclib) drug profile →More AstraZeneca trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06380751 on ClinicalTrials.gov ↗ ← All trials in Japan