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New drug cocktail aims to shrink Hard-to-Treat breast tumors

NCT ID NCT07389733

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests an experimental drug called HRS-6208 combined with other cancer drugs (HRS-8080, fulvestrant, or letrozole) in 180 adults with advanced breast cancer that cannot be removed by surgery or has spread. The main goals are to find safe doses and see if the combination shrinks tumors. Participants will be monitored for side effects and how long the cancer stays under control.

What this could mean

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

Active substance
HRS-6208 (an experimental drug) combined with other drugs like HRS-8080, fulvestrant, or letrozole
What this could lead to
If successful, this could lead to a new treatment option for people with advanced breast cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with only 180 participants, so the drugs may not work as hoped or could cause unexpected side effects. Results may not apply to all breast cancer patients.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 180 people

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

Started

Mar 2026

Expected to finish

Dec 2028

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, aged 18-75 (inclusive); 2. ECOG score 0-1; 3. Estimated survival time ≥ 12 weeks; 4. Possessing adequate bone marrow and organ function; 5. Participants of reproductive/childbearing potential must agree to take adequate and effective contraceptive measures from the time they sign the informed consent form, during the study treatment period, and up to 2 years after the last use of the trial medication; 6. Participants must provide informed consent for this study before the trial and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Within 5 years prior to the first dose of study medication, the occurrence of other malignancies, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and post-radical surgery thyroid papillary carcinoma; 2. Active brain metastasis, carcinomatous meningitis, spinal cord compression, or history of primary central nervous system tumors; 3. Severe bone damage caused by tumor bone metastasis as determined by the investigator; 4. Adverse events caused by previous anti-tumor treatment have not been resolved; 5. Participants with one of multiple factors affecting oral medication; 6. History of severe cardiovascular and cerebrovascular diseases; 7. Presence of severe infections; 8. Significant clinically meaningful bleeding within 3 months prior to the first dose of study medication; 9. Active autoimmune diseases, history of immune deficiency, history of autoimmune diseases, or history of diseases or syndromes requiring systemic steroid hormone or immunosuppressive drug treatment, or acquired conditions (HIV infection), congenital immune deficiency diseases, or history of organ transplantation; 10. Active untreated hepatitis; 11. History of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without standard treatment; 12. Washout period of prior drug or treatment did not meet protocol requirements before the first dose of study medication; 13. Prior use of prohibited drugs specified in the protocol; 14. Is pregnant or breastfeeding or planning to become pregnant within 2 years after the last dose of study medication; 15. History of clear neurological or psychiatric disorders, and participants with a history of psychiatric drug abuse or drug addiction; 16. Allergic reactions to any study drug or excipients; 17. Factors confirmed by the investigator as unsuitable for participation in this clinical study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • The Second Affiliated Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, 116031, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610044, China