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Trial Title:
Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
NCT ID:
NCT06449027
Condition:
Breast Cancer Subjects
Conditions: Official terms:
Breast Neoplasms
Tamoxifen
Leuprolide
Citric Acid
Sodium Citrate
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
T Leuprolide Injectable Emulsion
Description:
Arm 1 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48
weeks, and taked Tamoxifen Citrate Tablets 10mg bid for 48 weeks.
Arm group label:
Leuprolide Injectable Emulsion
Other name:
Tamoxifen Citrate Tablets
Intervention type:
Drug
Intervention name:
Leuprorelin Acetate Microspheres for Injection
Description:
Arm 2 subjects were injected Leuprorelin Acetate Microspheres for Injection 11.25mg every
12 weeks for 48 weeks, and taked Tamoxifen Citrate Tablets 10mg bid for 48 weeks.
Arm group label:
Leuprorelin Acetate Microspheres for Injection
Other name:
Tamoxifen Citrate Tablets
Summary:
The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide
Injectable Emulsion for Premenopausal Breast Cancer Subjects.
Detailed description:
This is a multicenter, randomized, open-Label , non-inferiority phase III study . All
premenopausal women breast cancer subjects were randomly allocated to either the study
group or control group in a 1:1 ratio. Furthermore, all subjects received tamoxifen
citrate treatment throughout the entire duration of the study. The efficacy of
maintaining serum E2 levels ≤30 pg/mL at 4-48 weeks post-treatment will be assessed in
both groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Premenopausal female subjects aged 18 to 55 years old.
- Histological or cytological confirmation of HR+，HER2- premenopausal breast cancer.
- Subjects have any breast cancer surgery before informing, and no clinical residual
local regional lesions were found after the surgery.
- Life expectancy is not less than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate function of major organs.
Exclusion Criteria:
- History of evidence of distant metastatic lesions;
- Subjects have the history of new adjuvant or adjuvant endocrine treatment for breast
cancer ( Excluding subjects receiving tamoxifen citrate tablets treatment for less
than 12 weeks before informing).
- Active hepatitis B, hepatitis C or HIV in screening.
Gender:
Female
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Jian Zhang, Doctor
Phone:
+86-21-64175590
Email:
Syner2000@163.com
Start date:
June 2024
Completion date:
March 2026
Lead sponsor:
Agency:
Changchun GeneScience Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Changchun GeneScience Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06449027
