Trials / Unknown
UnknownNCT05438810
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.
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- Sponsor
- Ahon Pharmaceutical Co., Ltd. · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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。 |
Timeline
- Start date
- 2022-01-18
- Primary completion
- 2024-02-18
- Completion
- 2024-05-18
- First posted
- 2022-06-30
- Last updated
- 2022-07-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05438810. Inclusion in this directory is not an endorsement.