SOLAR-1: A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment (CBYL719C2301)
- Conditions
- breast cancerhormone receptor positiveHER2-negative advanced breast cancer10006291
- Registration Number
- NL-OMON47797
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
* Postmenopausal (see protocol page 62 for details) females and males * 18
years of age.
* Adequate tumor tissue for analysis of PIK3CA mutational status. Identified
PIK3CA status.
* Histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+
HER2- breast cancer.
* Advanced disease. See protocol page 62 for details.
* Recurrence or progression of disease during or after aromatase inhibitor
therapy (i.e. letrozole, anastrozole, exemestane).
* Measurable disease or *1 predominantly lytic bone lesion. See protocol page
62 for details.
* ECOG performance status 0-1.
* Symptomatic visceral disease or ineligibility for endocrine treatment.
* Prior treatment with chemotherapy (except for neoadjuvant/ adjuvant
chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor.
* Child pugh score B or C.
* CNS involvement. Exceptions: see protocol page 64 for details.
* Diabetes mellitus type I or not controlled type II.
* Documented pneumonitis. See protocol page 64 for details.
* Clinically significant uncontrolled heart disease. See protocol page 64 for
details.
* Treatment with drugs with a known risk to prolong the QT interval or induce
Torsade de Pointes. Use of herbal preparations. Unless discontinued at least 14
days prior to start of study treatment.
* Systemic corticosteroids * 2 weeks prior to starting study drug, or who have
not fully recovered from side effects of such treatment.
* Sexually active males unless they are sterilized or use a condom during
intercourse during the use of study treatment and 8 months thereafter.
* History of acute pancreatitis within1 year of screening or past medical
history of chronic
pancreatitis
* Patient who relapsed with documented evidence of progression more than
12 months from
completion of (neo)adjuvant endocrine therapy with no treatment for metastatic
disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PFS</p><br>
- Secondary Outcome Measures
Name Time Method <p>OS, centrally assessed PFS, ORR, time to deterioration of ECOG performance<br /><br>status, adverse events, quality of life, PK parameters, association between<br /><br>PIK3CA mutation status and PFS.</p><br>