A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR-positive and HER2-negative Advanced Breast Cancer

Ahon Pharmaceutical Co., Ltd.1 site in 1 country434 target enrollmentMarch 2, 2022

ConditionsAdvanced Breast Cancer Female Breast Cancer

InterventionsFCN-437c, Letrozole or anastrozole, Goserelin acetate Placebo, Letrozole or anastrozole, Goserelin acetate

DrugsFCN-437c, Letrozole or anastrozole, Goserelin acetate Placebo, Letrozole or anastrozole, Goserelin acetate

Overview

Phase: Phase 3
Intervention: FCN-437c, Letrozole or anastrozole, Goserelin acetate
Conditions: Advanced Breast Cancer
Sponsor: Ahon Pharmaceutical Co., Ltd.
Enrollment: 434
Locations: 1
Primary Endpoint: PFS is determined by IRC
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of FCN-437c in combination with letrozole or anastrozole ± Goserelin versus placebo combined with letrozole or anastrozole ± Goserelin in women with first-line advanced breast cancer in HR+ and HER2-.

Registry

clinicaltrials.gov

Start Date

March 2, 2022

End Date

March 2, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ahon Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following conditions:
•Postmenopausal or premenopausal / peri-menopausal females aged≥18 years;
•Postmenopausal female is defined as:
•After bilateral oophorectomy; Age≥60 years Age\<60 years and menopause for more than 1 year without chemotherapy and treatment with tamoxifen, toremifene and ovarian function suppression, while blood FSH and estradiol levels meet the postmenopausal range and for postmenopausal patients who are taking tamoxifen or toremifene and who are younger than 60 years old, continuous detection of serum FSH and estradiol levels must meet the postmenopausal range.
•Females with advanced breast cancer diagnosed as HR+ HER2-。 HR+ positive is defined as：Histological and/or cytological confirmed ER+, PR + or -, defined as immunohistochemistry showing positive nuclear staining of estrogen/progesterone receptor tumor cells≥1%； HER2-negative is defined as：Histological and/or cytological confirmed HER2-， defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+,the ISH test result must be negative。
•There should be evidence of focal recurrence or metastasis, not suitable for surgical resection or radiation therapy for curative purposes, and without clinical indications for chemotherapy;。
•Patients who have not received any systemic anticancer therapy for focal recurrent or metastatic disease（Patients who had received aromatase inhibitors for advanced breast cancer for no more than 28 days or Goserelin for no more than 28 days prior to randomization are eligible for enrollment）. Patients with disease-free survival greater than 12 months after completion of adjuvant endocrine therapy are allowed to be enrolled.,
•ECOGperformance status 0-1。
•According to the RECIST 1.1 criteria, patients must have at least one measurable lesion, or patients with only bone metastases, if no measurable lesions are present, must have at least one bone lesion predominantly lytic.
•Note: If the lesion has received radiotherapy or other locoregional treatment, there must be imaging evidence of disease progression in the lesion after completion of treatment,and the lesion can be considered as a measurable lesion. For patients with no measurable lesion and only one osteolytic lesion, if the lesion was previously treated with radiotherapy, imaging evidence is needed to show the progression of bone lesions after radiotherapy..

Exclusion Criteria

•Patients who meet any of the following conditions are not allowed to enter this clinical study：
•Previously treated with CDK4 / 6 inhibitors;
•Disease progression orrecurrence during or within 12 months after receiving neoadjuvant therapy or adjuvant therapy with endocrine drugs;
•Received radiotherapy, chemotherapy, major surgery, tumor immunotherapy, monoclonal antitumor drug therapy, any investigational drug or other systemic anti-tumor therapy within 4 weeks before randomization;
•Patients with important organ metastasis or large tumor burden that are not suitable for endocrine therapy. For example, according to the investigator, the patient is not suitable for endocrine therapy:
•Symptomatic visceral metastasis;
•Rapid disease progression or impaired visceral function;
•Non-visceral metastases requiring chemotherapy according to the investigator's clinical judgment。
•Clinically suspected brain metastasis meningeal metastasis or unstable brain parenchymal metastasis, but stable brain metastasis can be enrolled. Stable brain metastasis is defined as: no expansion of the original metastatic lesions and no new lesions are found in the imaging reports at intervals of more than one month; No clinical symptoms, no need for hormone or other dehydrating treatment;
•Inflammatory breast cancer