breast cancer
Conditions
Interventions
investigational material(s)
Generic name etc :
INN of investigational material : alperisib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materia
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patient is a male or postmenopausal female > 18 years old. -Patient has adequate tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory. It is recommended to provide a tumor sample collected after the most recent progression or recurrence -Patient has identified PIK3CA mutant status determined by a Novartis designated laboratory
Exclusion criteria
Exclusion criteria: -Patient has received prior treatment with any PI3K inhibitors -Patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus -Patient has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanoma skin cancer or curatively resected cervical cancer -Patient has received radiotherapy < 4 weeks or limited field radiation for palliation < 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy -Patients receiving corticosteroids < 2 weeks prior to treatment. at the time of study entry except in cases outlined below: -Bilateral diffuse lymphangitis carcinomatosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed