None listed
Conditions
Interventions
Patients receive a daily oral dose (VO) 4 mg (two tablets 2 mg) of GDC 0032 or placebo according to a scheme of five days of administration / 2 days without administration for up to 16 weeks. Patients
Sponsors
GENENTECH, INC.,
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Female patients, postmenopausal status and age ≥ 18 years. • Histologically confirmed invasive breast carcinoma. • ER-positive and HER2-negative breast cancer, as per local laboratory or regional definition • Breast cancer eligible for primary surgery. • Tumor tissue from FFPE core biopsy of breast primary tumor that is confirmed as evaluable for PIK3CA mutation status by central histopathology laboratory. • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. • Fasting glucose ≤ 125 mg/dL. • Adequate hematological, renal, and hepatic function. • Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase ≤ 1.5 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min on the basis of the Cockcroft−Gault glomerular filtration rate estimation. • International normalized ratio (INR) < 1.5 × ULN and activated partial thromboplastin time (aPTT) < 1.5 × ULN. .For patients requiring anticoagulation therapy with warfarin, a stable INR between 2−3 is required. If anticoagulation is required for a prosthetic heart valve, then INR should be between 2.5−3.5. • Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. • Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol, in the investigator’s judgment.
Exclusion criteria
Exclusion criteria: • Patients with cT4 or cN3 stage breast tumors. • Metastatic (Stage IV) breast cancer, Bilateral invasive breast cancer or Multicentric breast cancer (the presence of more than one tumor in different quadrants of the breast). • Patients who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes. • Patients who have undergone sentinel lymph node biopsy prior to study treatment. • Patients for whom upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment. • Patients for whom immediate surgery is indicated. • Type 1 or 2 diabetes requiring antihyperglycemic medication. • Inability or unwillingness to swallow pills. • Malabsorption syndrome or other condition that would interfere with enteric absorption. • History of prior or currently active small or large intestine inflammation (such as Crohn’s disease or ulcerative colitis. • Congenital long QT syndrome or QT interval corrected using Fridericia’s formula (QTcF) > 470 msec. • DLCO < 60% of the predicted values . • Clinically significant (i.e., active) cardiovascular disease, uncontrolled hypertension. unstable angina, history of myocardial infarction, cardiac failure class II-IV, or any other that in the judgment of the investigator could jeopardize patient safety or study outcomes. • Any contraindication to MRI examination like Neurostimulators, Pacemakers and /or Implanted metallic material or devices .) or Known allergy or hypersensitivity reactions to gadolinium, versetamide and / or Severe renal insufficiency
Countries
Australia, Austria, Belgium, Brazil, Chile, El Salvador, France, Germany, Hungary, Italy, Korea North, Korea South, Mexico, Panama, Poland, Portugal, Spain, Switzerland, United Kindgdom, United States
Contacts
Public ContactCarolina De Tomas
ROCHE FARMA (PERU) S.A.
Outcome results
None listed