NCT01872260 - Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer | Biotech Hunter

Enrollment

255

Participants

Timeline

Start Date

October 22, 2013

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions

Breast Cancer

Interventions

DRUG

LEE011

LEE011 - 28 day cycles (21 days followed by a 7 day break) for Arms 1, 3. LEE011 28 days cycles (continuous) Arm 4.

DRUG

Letrozole

Letrozole 2.5 mg/day

DRUG

BYL719

BYL719 - 28 days cycle (continuous) for Arm 2; 3 and 4

Trial Locations (25)

2145

Novartis Investigative Site, Westmead

3050

Novartis Investigative Site, Parkville

6009

Novartis Investigative Site, Nedlands

6500

Novartis Investigative Site, Bellinzona

13273

Novartis Investigative Site, Marseille

28009

Novartis Investigative Site, Madrid

28050

Novartis Investigative Site, Madrid

33612

H Lee Moffitt Cancer Center and Research Institute, Tampa

37203

Sarah Cannon Research Institute, Nashville

37232

Vanderbilt University Medical Ctr, Nashville

41013

Novartis Investigative Site, Seville

44805

Novartis Investigative Site, Saint-Herblain

46010

Novartis Investigative Site, Valencia

56126

Novartis Investigative Site, Pisa

75246

Texas Oncology, Dallas

75475

Novartis Investigative Site, Paris

78229

Mays Cancer Ctr Uthsa Mdacc, San Antonio

92103

Univ of California at San Diego Moores Cancer Ctr, San Diego

94143

UCSF Medical Center, San Francisco

98405

Northwest Medical Specialties, Tacoma

02114

Massachusetts General Hospital SC-5, Boston

Massachusetts General Hospital, Boston

03080

Novartis Investigative Site, Seoul

G12 0YN

Novartis Investigative Site, Glasgow

M20 2BX

Novartis Investigative Site, Manchester