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

What Was Tested

This registered phase 2 trial tested Goserelin.

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.

It had two arms (groups): FCN-437c with Fulvestrant (experimental) and FCN-437c in combination with Letrozole + Goserelin (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 70 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects are eligible to be included in the study only if they meet all of the following criteria:. Criteria of menopausal status and prior treatment, and see Appendix 3 for definition of menopause:. ECOG (Eastern Cooperative Oncology Group) performance status score at 0 or 1;. Life expectancy for at least 12 weeks;. The bone marrow and organ function of the patient should be adequate:.

The full record lists 15 inclusion and 26 exclusion criteria; among the exclusions: patients that meet any of the following conditions shall not be included in this clinical study:; prior treatment criteria:; prior treatment with a cdk4/6 inhibitor;.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-06-30 with completion listed for 2021-12-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Overall response rate (time frame: through study completion, assessed up to 24 months).

It also tracked 9 secondary outcomes, for example Safety and tolerability of the combination therapy, PFS, OS, 1-year overall survival rate, DOR and CBR.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Goserelin in 70 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.