Study of Efficacy, Safety, and Pharmacokinetics of FCN-437c in Combination With Fulvestrant or Letrozole+Goserelin

PHASE2UnknownINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

June 30, 2020

Primary Completion Date

December 30, 2021

Study Completion Date

June 30, 2023

Conditions
Breast Neoplasms
Interventions
DRUG

FCN-437c+Fulvestrant

FCN-437c 200mg, oral administration under fasting conditions, QD, for 21 days, with 7-day discontinuation, 28 days for 1 cycle; Fulvestrant, C1D1 and C1D15 and Day 1 of each cycle, 500mg/day, intramuscularly.

DRUG

FCN-437c+Letrozole+Goserelin

FCN-437c 200mg, oral administration under fasting conditions, QD, for 21 days, with 7-day discontinuation, 28 days for 1 cycle; Letrozole 2.5 mg, QD, for continuous dosing; Goserelin 3.6 mg, subcutaneously, once every 28 days.

Trial Locations (1)

Unknown

RECRUITING

Fourth Hospital of Hebei Medical University, Shijiazhuang

Sponsors
All Listed Sponsors
collaborator

Hebei Medical University Fourth Hospital

OTHER

collaborator

The First Hospital of Jilin University

OTHER

collaborator

Affiliated Hospital of Hebei University

OTHER

lead

Ahon Pharmaceutical Co., Ltd.

OTHER