A PHASE II RANDOMIZED, DOUBLE-BLIND STUDY OFNEOADJUVANT LETROZOLE PLUS GDC-0032 VERSUSLETROZOLE PLUS PLACEBO IN POSTMENOPAUSAL WOMENWITH ER-POSITIVE/HER2- NEGATIVE, EARLY STAGE BREAST CANCER.
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-009-15
- Lead Sponsor
- GENENTECH, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 4
• 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.
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method