NCT02058381 - A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 6, 2014

Primary Completion Date

June 19, 2018

Study Completion Date

June 19, 2018

Conditions

Pre-menopausal Breast CancerPI3K Pathway Inhibition

Interventions

DRUG

alpelisib (BYL719)

BYL 719 350 mg will be administered orally once daily on a continuous dosing schedule starting on day 1 (Group 1 only).

DRUG

buparlisib (BKM120)

BKM120 100 mg will be administered orally once daily on a continuous dosing schedule starting on day 1 (Group 2 only)

Trial Locations (15)

112

Novartis Investigative Site, Taipei

407

Novartis Investigative Site, Taichung

10002

Novartis Investigative Site, Taipei

10330

Novartis Investigative Site, Bangkok

10408

Novartis Investigative Site, Gyeonggi-do

10449

Novartis Investigative Site, Taipei

13620

Novartis Investigative Site, Seongnam-si

23561

Novartis Investigative Site, New Taipei City

33305

Novartis Investigative Site, Kuei-Shan Chiang

50200

Novartis Investigative Site, Chiang Mai

83301

Novartis Investigative Site, Kaohsiung City

Unknown

Novartis Investigative Site, Hong Kong

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul