NCT02333370 - A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 4, 2015

Primary Completion Date

September 29, 2022

Study Completion Date

September 29, 2022

Conditions

Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Interventions

DRUG

LEE011

LEE011 as 50 mg and 200 mg hard gelatin oral capsules as individual patient supply packaged in bottles. LEE011 will be taken QD - days 1-21 of each 28 days cycle.

DRUG

Letrozole

25mg

DRUG

Tamoxifen

20 mg

DRUG

Fulvestrant

500 mg

DRUG

goserelin

Trial Locations (15)

168583

Novartis Investigative Site, Singapore

Unknown

Novartis Investigative Site, Hong Kong

467-8602

Novartis Investigative Site, Nagoya

003-0804

Novartis Investigative Site, Sapporo

241-8515

Novartis Investigative Site, Yokohama

540-0006

Novartis Investigative Site, Osaka

565 0871

Novartis Investigative Site, Suita

350-1298

Novartis Investigative Site, Hidaka

362-0806

Novartis Investigative Site, Kitaadachi-gun

411 8777

Novartis Investigative Site, Sunto Gun

113-8431

Novartis Investigative Site, Bunkyo Ku

113-8677

Novartis Investigative Site, Bunkyo Ku

135 8550

Novartis Investigative Site, Koto Ku

142-8666

Novartis Investigative Site, Shinagawa-ku

160-0023

Novartis Investigative Site, Shinjuku-ku