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New shot could help control breast cancer in younger women

NCT ID NCT06449027

Disease control Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new injectable form of leuprolide in 211 premenopausal women with hormone-positive breast cancer. The goal is to see if it can safely keep estrogen at postmenopausal levels for nearly a year, which helps control cancer growth. Participants receive the drug and are monitored for hormone levels and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

211 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer subjects

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China