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New hope for breast cancer: experimental combo enters human trials

NCT ID NCT07358377

Disease control Sponsor: Atridia Pty 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called HRS-6209 combined with standard hormone therapies (fulvestrant or letrozole) in people with a certain type of advanced breast cancer (HR-positive/HER2-negative). The main goal is to check safety and find the right dose. About 15 participants will be enrolled.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

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

Started

May 2026

Expected to finish

Nov 2027

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 years and older

Sex

Anyone

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. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial. 2. Adequate bone marrow and other vital organ functions 3. Adequate liver function tests 4. HR-positive or HER2-negative solid tumor patients Exclusion Criteria 1. Plan to receive any other anti-tumor therapy during the study. 2. Active brain metastases . 3. Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure. 4. Previous use of fulvestrant 5. clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding. 6. With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease). 7. With acute or active tuberculosis infection requiring medication. 8. Pregnant or lactating women, or females planning to become pregnant During the study. 9. Known history of clinically significant liver disease, untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\] positive

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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

    6 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

  • Ballarat Base Hospital

    RECRUITING

    Ballarat, Victoria, Australia

  • Frankston Hospital

    RECRUITING

    Frankston, Victoria, Australia

  • GenesisCare Frenchs Forest

    RECRUITING

    Sydney, New South Wales, 2086, Australia

  • GenesisCare St Leonards

    RECRUITING

    Sydney, New South Wales, 2068, Australia

  • Lyell McEwin Hospital

    RECRUITING

    Elizabeth Vale, South Australia, Australia

  • Southern Highlands Private Hospital

    RECRUITING

    Bowral, New South Wales, 2567, Australia

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