Study of Efficacy, Safety, and Pharmacokinetics of FCN-437c in Combination With Fulvestrant or Letrozole+Goserelin
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This is a multicenter, open-label clinical study to evaluate the safety and antitumor
activity of FCN-437c in combination with Fulvestrant for the treatment of post-menopausal
female patients with ER+ and HER2- advanced breast cancer, FCN-437c in combination with
Letrozole + Goserelin for the treatment of pre-menopausal female patients with ER+ and HER2-
advanced breast cancer, and to evaluate the PK characteristics of the FCN-437c combination
therapies.
This study is consist of two cohorts, Cohort 1: FCN-437c in combination with Fulvestrant (1st
or 2nd line treatment for postmenopausal ER+, HER2-advanced breast cancer); Cohort 2:
FCN-437c in combination with Letrozole + Goserelin (1st line treatment for premenopausal ER+,
HER2- advanced breast cancer). Thirty patients will be enrolled in each cohort, for a total
of 60 patients.
Tumor Assessment:
Tumor evaluation will be performed every 8 weeks (±7 days) according to RECIST version 1.1
until disease progression, withdrawal of informed consent, or death; for patients who
discontinue the drug due to toxicity, imaging evaluation is required until disease
progression.
End of Treatment and End of Study:
End of Study (EOS) is defined as 2 years after the last patient's first dose or the end of
treatment (whichever is earlier). At the end of the study, the investigator will decide
whether the patients whose disease has not progressed shall continue taking FCN-437c and
other combination agents or not based on clinical benefit.
Cohort 1: Post-menopausal patients diagnosed with ER+, HER2- advanced breast cancer, who have
not received prior systemic therapy for advanced breast cancer, or who have disease
progression determined by imaging assessment during their 1st line endocrine therapy; Cohort
2: Pre-menopausal patients diagnosed with ER+, HER2- advanced breast cancer, who have not
received prior systemic therapy for advanced breast cancer;
Phase:
Phase 2
Details
Lead Sponsor:
Ahon Pharmaceutical Co., Ltd.
Collaborators:
Affiliated Hospital of Hebei University Hebei Medical University Fourth Hospital The First Hospital of Jilin University