New drug cocktail HRS-6209 shows promise in early breast cancer trial
NCT ID NCT06974929
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called HRS-6209, taken as a capsule, combined with either letrozole or another drug HRS-2189 in 80 women with breast cancer. The goal is to find a safe dose and see if the combination can shrink tumors. It is an early-stage trial, so the main focus is on safety and tolerability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-6209 (a drug taken by mouth) combined with either letrozole or HRS-2189
- What this could lead to
- If successful, this could point toward a new combination treatment option for breast cancer that may help shrink tumors or slow disease progression.
- What could go wrong
- This is an early-phase trial with only 80 participants, so it is primarily testing safety and dosing. The combination may not prove effective against breast cancer, and side effects could limit its use.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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. Women aged 18-75 years. 2. ECOG performance status 0-1. 3. Menopausal status. 4. Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration. 5. At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria. 6. Expected survival \> 3 months. 7. Women of childbearing potential must agree to use highly effective contraceptive measures during the study treatment and for 6 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding. 8. Voluntarily agree to participate in this clinical trial, willing and able to comply with the study visits and procedures, understand the study procedures, and have signed the informed consent form. Exclusion Criteria: 1. Symptomatic visceral metastasis and other conditions, and the researcher judged that endocrine therapy was not suitable for use. 2. History of clinically serious cardiovascular disease. 3. The ECG examination was abnormal. 4. Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding. 5. The subjects were in acute infection or active tuberculosis and needed drug treatment. 6. The patients received surgery, chemotherapy, immunotherapy and macromolecular targeted therapy within 4 weeks before the first medication. 7. Pregnant and lactating women, or intending to become pregnant during the study. 8. There was a clear history of neurological or mental disorders and the subjects had a history of psychotropic drug abuse or drug abuse. 9. In the course of this study, it is expected to receive other anti-tumor treatments or drugs.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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