A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of FCN-437c Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer

Ahon Pharmaceutical Co., Ltd.1 site in 1 country312 target enrollmentJanuary 18, 2022

ConditionsAdvanced Breast Cancer Female Breast Cancer

InterventionsFCN-437c,Fulvestrant,Goserelin acetate Placebo,Fulvestrant,Goserelin acetate

DrugsFCN-437c,Fulvestrant,Goserelin acetate Placebo,Fulvestrant,Goserelin acetate

Overview

Phase: Phase 3
Intervention: FCN-437c,Fulvestrant,Goserelin acetate
Conditions: Advanced Breast Cancer
Sponsor: Ahon Pharmaceutical Co., Ltd.
Enrollment: 312
Locations: 1
Primary Endpoint: PFS is determined by the IRC
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 fluvestrant ± goseraline versus placebo in combination with fluvestrant ± goseraline in women with HR+ and HER2- advanced breast cancer.

Registry

clinicaltrials.gov

Start Date

January 18, 2022

End Date

May 18, 2024

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:
•Female advanced breast cancer patients aged ≥18 years, 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。
•Arbitrary menopausal status.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..
•Previous treatment criteria: Second-line and above patients can be included in the group。
•Previous treatment criteria: Second-line and above patients can be enrolled. Eastern cooperative oncology group (ECOG) 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.。
•Life expectancy is not less than 12 weeks;
•Adequate bone marrow and organ function:

Exclusion Criteria

•Patients who meet any of the following conditions are not allowed to enter this clinical study：
•The exclusion criteria for prior treatment are as follows
•Patients who received prior treatment with any CDK4/6 inhibitors or fulvestrant or everolimus;
•Received more than first-line systemic chemotherapy for advanced breast cancer.;
•Received endocrine therapy within 2 weeks prior to initial administration;
•Received radiotherapy, major surgery, tumor immunotherapy, monoclonal antitumor drug therapy, and other systemic antitumor therapies that the investigator considered would interfere with the efficacy of the investigational drug within 4 weeks prior to initial administration.
•Patients with visceral crises who are not suitable for endocrine therapy.
•Inflammatory breast cancer.
•Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to initial administration).
•Any other malignancy diagnosed within 3 years prior to participation in this study, except radically treated early stage malignancies (carcinoma in situ or stage I tumors) , such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.