None listed
Conditions
Interventions
The taselisib tablet is a white to off-white, film coated, immediate release formulation of 2-mg strength. The taselisib 4-mg dose will be taken orally (PO) once a day (QD). Taselisib is formulated as
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Women with histologically or cytologically confirmed invasive, ER+ breast cancer:metastatic or inoperable (not amenable to resection or other local therapy with curative intent) locally advanced breast cancer. • Patients for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study. • Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer. • Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an AI, or progression while on or within 1 month of the end of prior AI treatment for locally advanced or MBC. The AI (letrozole, anastrozole, or exemestane) does not have to be the most recent treatment before randomization. • Measurable disease via RECIST v1.1 or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1. Bone lesions that have been irradiated are not evaluable. • Able and willing to provide written informed consent and to comply with the study protocol. • Age ≥ 18 years. • ECOG of 0 or 1. • Postmenopausal status. • Consent to provide a formalin-fixed paraffin. • A valid cobas PIK3CA mutation result. • Adequate hematologic and end-organ function. • Fasting glucose ≤ 125 mg/dL (6.94 mmol/L)
Exclusion criteria
Exclusion criteria: • HER2-positive • Prior treatment with fulvestrant. • Prior treatment with a PI3K, mTOR, or AKT inhibitor. • Prior anti-cancer therapy within 2 weeks prior to Cycle 1 Day 1. • Prior radiation therapy within 2 weeks prior to Cycle 1 Day 1. • All acute treatment-related toxicity must have resolved to Grade ≤ 1 or be deemed stable. • Prior treatment with > 1 cytotoxic chemotherapy regimen for MBC. • Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy. • Concurrent hormone replacement therapy. • Known untreated or active CNS metastases. •History of other malignancy. • Type 1 or Type 2 diabetes mellitus requiring medications. • Clinically significant cardiac or pulmonary dysfunction • Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living. • History of malabsorption syndrome or other condition that would interfere with enteral absorption. • Inability or unwillingness to swallow pills or receive intramuscular injections. • Clinically significant history of liver disease. • History of inflammatory bowel disease. • Active bowel inflammation. • Immunocompromised status. • Pregnancy, lactation, or breastfeeding. • Current severe, uncontrolled systemic disease. • Major surgical procedure within 28 days prior to Cycle 1 Day 1 or anticipation of the need for major surgery during the course of study treatment • Inability to comply with study. • Inability to understand EORTC QLQ-C30, QLQ-BR23, and the EQ-5D questionnaires are available.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dominican Republic, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Israel, Italy, Japan, Korea South, Latovia, Mexico, Netherlands, Panama, Paraguar, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactRoberto Carrasco
ROCHE FARMA (PERU) S.A.
Outcome results
None listed