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New pill could keep early breast cancer from coming back

NCT ID NCT07349069

Disease control Sponsor: Shandong Suncadia Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial compares a new drug, HRS-8080, against standard hormone therapies (like letrozole or tamoxifen) in 5,500 women with intermediate or high risk early breast cancer who have already completed at least 2 years of standard hormone treatment. The goal is to see if HRS-8080 better prevents the cancer from returning or spreading. Participants will be randomly assigned to receive either HRS-8080 or a standard therapy for up to 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRS-8080 tablets
What this could lead to
If successful, this could offer a more effective treatment option to reduce the risk of breast cancer returning in patients with intermediate or high risk early breast cancer.
What could go wrong
This is a large Phase 3 trial, but results are not yet available. HRS-8080 may not prove better than standard therapies, and side effects are possible. The study is still recruiting, so outcomes are uncertain.

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

About 5,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jan 2034

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 75 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: 1. Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period. 2. Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy. 3. No evidence of recurrent or metastatic disease after surgery. 4. ECOG performance status of 0 or 1. 5. Adequate organ and bone marrow function. 6. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and be willing to use acceptable non-hormonal contraception methods from the time of informed consent until 7 months after the last dose of the study drug. 7. Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0). 8. The patient has provided written informed consent (ICF), and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Tumor clinical stage IV (metastatic) breast cancer. 2. History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization. 3. History of severe pulmonary disease, such as interstitial lung disease. 4. Concurrent or potential use of any anti-tumor therapy not specified in the study protocol. 5. Major surgical procedure within 4 weeks prior to randomization. 6. HIV infection or known AIDS, active hepatitis B, hepatitis C, or co-infection with hepatitis B and C. 7. Poor cardiac function. 8. Severe infection within 4 weeks prior to randomization. 9. History of drug allergy. 10. History of organ transplantation. 11. History of substance abuse. 12. Women within 1 year postpartum or who are currently breastfeeding. 13. Patients deemed by the investigator as unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • The First Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210029, China

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