A phase II randomized, double-blind placebo controlled, study of letrozole with or without BYL719 or buparlisib, for the neoadjuvant treatment of postmenopausal women with hormone receptor-positive HER2-negative breast cancer.

Phase 1

• Conditions: neoadjuvant hormone-receptor positive HER2-negative breast cancer; MedDRA version: 16.0Level: LLTClassification code 10006204Term: Breast carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001862-41-IT
• Lead Sponsor: ovartis Farma S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-10
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 372

Inclusion Criteria

--patient has T2-T4, any N, M0 breast cancer and measurable tumor
--diagnostic biopsy available for analysis of PIK3CA mutation, ER/PR, HER2 status and Ki67 levels
--estrogen-receptor and/or proesterone positive breast cancer as per local or Novartis central lab test
--HER2 negative breast cancer
--known PIK3CA mutation status
--Ki67 level status determined centrally
--ECOG performance status < or = 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 335

Exclusion Criteria

--locally recurrent or metastatic disease
--patient has received any systemic therapy (eg chemo-, targeted- or immuno-therapy) or radio-therapy for current disease
--patient with clinically manifest diabetes mellitus (fasting glucose >120mg/dl or 6.7 mmol.L), or documented steroid induced diabetes mellitus
--score of > or = 12 on the PHQ-9 questionnaire
--patient selects response of 1,2,or 3 to question number 9 on PHQ-9 questionnaire
--GAD-7 mood scale score > or = 15
--medically documented history of or active major depressive episode, bipolar disorder, obsessive compulsive disorder, schizophrenia, history of suicide attempt or ideation or homicidal ideation, or active severe personality disorder
--patient has > or = CTCAE grate 3 anxiety

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified