Breast Cancer SubjectsPhase 3NCT06449027
Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
A Phase 3 study testing T Leuprolide Injectable Emulsion and Leuprorelin Acetate Microspheres for Injection in people with Breast Cancer Subjects, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Breast Cancer Subjects
- What is being tested?
- T Leuprolide Injectable Emulsion and Leuprorelin Acetate Microspheres for Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2024to Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase III, Multicenter, Randomized, Open-Label Study to Assess the Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
Read the 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.
- Conditions
- Breast Cancer Subjects
- Being tested
- T Leuprolide Injectable Emulsion, Leuprorelin Acetate Microspheres for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T Leuprolide Injectable EmulsionDrug
Also called Tamoxifen Citrate Tablets
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.
Leuprorelin Acetate Microspheres for InjectionDrug
Also called Tamoxifen Citrate Tablets
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.
| Study group | Role | What they receive |
|---|---|---|
| Leuprolide Injectable Emulsion | Experimental | 100 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48 weeks. Receives: Drug: T Leuprolide Injectable Emulsion |
| Leuprorelin Acetate Microspheres for Injection | Active comparator | 100 subjects were injected Leuprorelin Acetate Microspheres for Injection 11.25mg every 12 weeks for 48 weeks. Receives: Drug: Leuprorelin Acetate Microspheres for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (3)
Observe the concentration of LH, FSH, E2 after treatment.
Measured: 48 weeks
Pharmacokinetic Parameter(AUC)
Measured: 48 weeks
Pharmacokinetic Parameter(Cmax)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start21 Aug 2024
- Primary completionNov 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SubjectsStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Zhang, Doctor, Principal investigator, Fudan UniversityZhimin Shao, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449027
- Sponsor's protocol ID
- GenSci093-301
- Status last verified
- Sep 2025
- First submitted
- 31 May 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Open-Label Study to Assess the Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
- ClinicalTrials.gov ID
- NCT06449027
- Acronym / sponsor ID
- GenSci093-301
- Conditions
- Breast Cancer Subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leuprolide Injectable Emulsion | Experimental | Drug: T Leuprolide Injectable Emulsion100 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48 weeks. |
| Leuprorelin Acetate Microspheres for Injection | Active comparator | Drug: Leuprorelin Acetate Microspheres for Injection100 subjects were injected Leuprorelin Acetate Microspheres for Injection 11.25mg every 12 weeks for 48 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T Leuprolide Injectable EmulsionAlso: Tamoxifen Citrate TabletsArm 1 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48 weeks, and taked Tamoxifen Citrate Tablets 10mg bid for 48 weeks. | Drug | Leuprolide Injectable Emulsion |
| Leuprorelin Acetate Microspheres for InjectionAlso: Tamoxifen Citrate TabletsArm 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. | Drug | Leuprorelin Acetate Microspheres for Injection |
Primary outcome
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.
Time frame: 48 weeks
3 secondary outcomes
Observe the concentration of LH, FSH, E2 after treatment.
Time frame: 48 weeks
Pharmacokinetic Parameter(AUC)
Time frame: 48 weeks
Pharmacokinetic Parameter(Cmax)
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Zhang, Doctor principal investigator
Fudan University
Zhimin Shao, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T Leuprolide Injectable Emulsion and Leuprorelin Acetate Microspheres for Injection in people with Breast Cancer Subjects, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.