Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
SOLTI Breast Cancer Research Group
Breast International Group
Austrian Breast & Colorectal Cancer Study Group
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female participants
Postmenopausal status
Histologically confirmed invasive breast carcinoma, with all of the following characteristics: (i) Primary tumor greater than or equal to (\>/=) 2 centimeters (cm) in largest diameter (cT1-3) by MRI; (ii) Stage I to operable Stage III breast cancer; (iii) Documented absence of distant metastases (M0)
Estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer
Breast cancer eligible for primary surgery
Tumor tissue from formalin-fixed paraffin-embedded cores (FFPE) core biopsy of breast primary tumor that is confirmed as evaluable for phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation status by central histopathology laboratory
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Fasting glucose less than or equal to (\</=) 125 milligrams per deciliter (mg/dL)
Adequate hematological, renal, and hepatic function
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
You may not be if
Any prior treatment for primary invasive breast cancer
Participants with cT4 or cN3 stage breast tumors
Bilateral invasive, multicentric, or metastatic breast cancer
Participants who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy
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). Any predisposition for gastrointestinal (GI) toxicity requires prior approval from the Medical Monitor.
Congenital long QT syndrome or QT interval corrected using Fridericia's formula (QTcF) \>470 milliseconds (msec)
Diffusing capacity of the lungs for carbon monoxide (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
Any contraindication to MRI examination
Active infection requiring intravenous antibiotics
Participants requiring any daily supplemental oxygen
Clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis
Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the participants at high risk from treatment complications
Significant traumatic injury within 3 weeks prior to initiation of study treatment
Major surgical procedure within 4 weeks prior to initiation of study treatment
Inability to comply with study and follow-up procedures
History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
Clareo Health | A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
