Active — Not RecruitingPhase 3

Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

China211 participantsStarted 2024-08-21

Plain-language summary

The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Observe the proportion of subjects whose E2 levels remain at postmenopausal levels between 4 and 48 weeks after treatment, to assess the Efficacy of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subject.

Timeframe: 48 weeks

Trial details

NCT IDNCT06449027

SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11

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