NCT05004142

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

Evaluation of the Antitumor Activity, Safety, and Pharmacokinetic Profile of FCN-437c in Combination With Fulvestrant or Letrozole + Goserelin in Female Patients With ER+, HER2- Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Ahon Pharmaceutical Co., Ltd. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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;

Detailed description

Screening period (Day-28 to Day-1); * Continuous dose treatment period: 28 days for each treatment cycle, with patients evaluated every 8 weeks until disease progression, withdrawal of informed consent or death; for patients discontinued due to toxicity, imaging evaluation is required until disease progression; * Follow-up after the end of treatment (within 30 days from the last dose); * Survival follow-up (once telephone follow-up every 3 months until the end of study); Primary Objectives: * To observe the efficacy and safety of continuous oral administration of FCN-437c in combination with Fulvestrant in post-menopausal female patients with ER+, HER2- advanced breast cancer; * To observe the efficacy and safety of continuous oral administration of FCN-437c in combination with Letrozole + Goserelin in pre-menopausal female patients with ER+, HER2- advanced breast cancer; Secondary Objectives: * To characterize the PK profile of FCN-437c in combination with Letrozole + Goserelin; * To characterize the PK profile of FCN-437c in combination with Fulvestrant; End of study: 2 years after the last patient's first dose or the end of treatment (whichever is earlier);

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-30
• Primary completion: 2021-12-30
• Completion: 2023-06-30
• First posted: 2021-08-13
• Last updated: 2021-08-13

Locations

1 site across 1 country: China