Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy (SUBITO) an international randomized phase III trial
Phase 3
Recruiting
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON56057
- Lead Sponsor
- ederlands Kanker Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 94
Inclusion Criteria
- Women and men with stage III adenocarcinoma of the breast harboring signs of
a breast cancer with features of homologous recombination deficiency (HRD)
- Age of 18-65 years
- The tumor must be HER2-negative
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria
- Distant metastases
- Previous radiation therapy
- Previous chemotherapy
- Any previous treatment with a PARP-inhibitor, including olaparib
- Pre-existing neuropathy from any cause in excess of Grade 1
- Chronic concomitant use of known strong or moderate CYP3A inducers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is overall survival defined as the time from randomization to<br /><br>death from any cause.in all patients</p><br>
- Secondary Outcome Measures
Name Time Method