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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 Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.

NCT05438810 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2022-07-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

FCN-437c,Fulvestrant,Goserelin acetate

FCN-437c：available in 25mg and 100mg capsules for oral administration on an empty stomach. 200mg once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment until progressive disease。 Fulvestrant：500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles ； Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。

DRUG

Placebo,Fulvestrant,Goserelin acetate

Placebo：available in 25mg and 100mg capsules, and is administered in the same way as FCN-437c。 Fulvestrant：500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles； Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。

Sponsors & Collaborators

  • Ahon Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • Xichun Hu · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2024-02-18
Completion
2024-05-18

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT05438810 on ClinicalTrials.gov