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 (CBYL719A2201)

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 (CBYL719A2201) - CBYL719A2201 NEO-Belle/Neo-Orb

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45221

Enrollment

Registered

2013-11-12

Start date

2015-02-03

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Treatment with letrozole ± BYL719

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Postmenopausal women (at time of breast cancer diagnosis) with HR+ HER2- breast cancer, Tc1-T3, M0 operable. See protocol page 49 for details. * 18 years and above. * Measurable disease. * Biopsy available for the analysis of PIK3CA mutation and Ki67 level. Results known. * ECOG performance status 0-1.

Exclusion criteria

Exclusion criteria: * Recurrent or metastatic disease. * Any systemic therapy or radiotherapy for current breast cancer. * Patients with type 1 diabetes mellitus, or not adequatly type 2 diabetes mellitus. * Left Ventricular Ejection Fraction

Design outcomes

Primary

Measure	Time frame
pCR. and ORR based on tumor tissue	—

Secondary

Measure	Time frame
pCR and ORR based on cDNA, adverse events, breast conserving surgery, Ki67, PK parameters.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)