MedTrace Logo

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

NCT05004142 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-08-13

No results posted yet for this study

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;

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.

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • The First Hospital of Jilin University

    collaborator OTHER

  • Affiliated Hospital of Hebei University

    collaborator OTHER

  • Ahon Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • Yunjiang Liu, Doctor · Hebei Medical University Fourth Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-12-30
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05004142 on ClinicalTrials.gov