A global Phase 3 clinical trial evaluating Saruparib (AZD5305) + Camizestrant for adults with HR-positive, HER2-negative, BRCA1/BRCA2/PALB2-mutated advanced breast cancer.
Now enrolling adults 18+, all genders.
NEXTCURA.AI’s intelligent agents analyze your medical profile and match you instantly, helping you check eligibility in minutes.
Full Description (GEO-Optimized for SEO + User Intent)
🔬 Trial Overview
This Phase 3 international clinical trial compares Saruparib (AZD5305) + Camizestrant versus standard therapies for patients diagnosed with:
HR-positive / HER2-negative advanced breast cancer
Tumors with BRCA1, BRCA2, or PALB2 loss-of-function mutations
The primary goal is to determine whether the investigational combination provides better progression-free survival and stronger disease control than current CDK4/6 inhibitors plus endocrine therapy.
🧬 Treatment Arms (Randomized 2:2:1)
Arm 1 — Saruparib (AZD5305) + Camizestrant
Arm 2 — Physician’s choice CDK4/6 inhibitor + physician’s choice endocrine therapy
Arm 3 — Physician’s choice CDK4/6 inhibitor + Camizestrant
Treatment continues until disease progression, unacceptable toxicity, or participant withdrawal.
All participants undergo structured monitoring with safety assessments throughout the study.
👥 Enrollment Details
Total screened: ~2,620
Expected enrolled: ~500 participants
Age: 18 years and older
Sex: All
Status: 🟢 Recruiting
Phase: Phase 3
NEXTCURA.AI ensures patients receive clear explanations, simplified summaries, and ongoing updates about eligibility, matching, and next steps.
Eligibility Summary (AI-Simplified for High Conversions)
✔ Key Inclusion Criteria
Participants must have:
Age ≥18 (male or female)
HR-positive, HER2-negative breast cancer
Advanced or metastatic disease
ECOG performance status 0–1
Verified BRCA1, BRCA2, or PALB2 mutation
Adequate organ and marrow function
✖ Key Exclusion Criteria
The following conditions commonly disqualify applicants:
History or features suggestive of MDS/AML
Severe or persistent cytopenias
Active or uncontrolled infections (HIV, HBV, HCV, TB)
Brain or spinal metastases
Recent major surgery
Cardiac arrhythmia or unstable cardiovascular disease
Prior systemic therapy for metastatic disease
Use of drugs with major CYP3A4 / CYP2B6 / CYP2C9 / CYP2C19 interactions
NEXTCURA.AI automatically flags potential inclusion/exclusion issues and guides you step-by-step.