A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.

Key facts

Study ID

NCT02273973

Run by

Genentech, Inc.

People needed

334

Starts

2014-11-12

Expected to finish

2017-03-13

Last updated by the study team

2018-05-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• MGH Cancer Center — Boston, Massachusetts, United States
• MSKCC at Basking Ridge — Basking Ridge, New Jersey, United States
• MSKCC @ Commack — Commack, New York, United States
• MSKCC @ West Harrison — Harrison, New York, United States
• Memorial Sloan-Kettering Cancer Center; Hematology/Oncology — New York, New York, United States
• MSKC @ Rockville — Rockville Centre, New York, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Kinghorn Cancer Centre; St Vincents Hospital — Darlinghurst, New South Wales, Australia
• Newcastle Mater Misericordiae Hospital; Oncology — Waratah, New South Wales, Australia
• Victorian Breast and Oncology Care — East Melbourne, Victoria, Australia
• Cabrini Medical Centre; Oncology — Malvern, Victoria, Australia
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie — Graz, Austria
• LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie — Graz, Austria
• Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie — Innsbruck, Austria
• Ordensklinikum Linz Barmherzige Schwestern ; Abt. f. Allgemein- und Viszeralchirurgie — Linz, Austria
• Brustzentrum - Ordination Dr. Wette — Saint Veit/Glan, Austria
• Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. — Salzburg, Austria
• Medizinische Universität Wien; Univ.Klinik für Chirurgie - Abt. für Allgemeinchirurgie — Vienna, Austria
• Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie — Vienna, Austria
• Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe — Vienna, Austria
• Klinikum Kreuzschwestern Wels; Iii. Interne Abt. — Wels, Austria
• Institut Jules Bordet — Brussels, Belgium
• CHU Brugmann (Victor Horta) — Brussels, Belgium
• Breastlink Med Group Inc — Santa Ana, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.