New hope for tough breast cancer: drug combo trial launches
NCT ID NCT07111832
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether a new combination of drugs (SHR-A1811 plus SHR-1316) works better than the current standard treatment for a specific type of advanced breast cancer called PD-L1-positive triple-negative breast cancer. The study will enroll 400 women whose cancer has come back or spread and cannot be removed by surgery. The main goal is to see if the new combo delays cancer growth longer than the standard therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-A1811 (a targeted drug) plus SHR-1316 (an immunotherapy)
- What this could lead to
- If successful, this could offer a new first-line treatment option for people with a hard-to-treat form of advanced breast cancer, potentially improving how long the cancer stays under control.
- What could go wrong
- This is an early-stage phase 3 trial, so results are not yet known. The new combination may not work better than the current standard treatment, and side effects could be serious.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2028
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. Age 18-75 years old (including both ends), female. 2. Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer. 3. Expected survival ≥ 12 weeks. 4. Have adequate renal and hepatic function. 5. Patients voluntarily joined the study and signed the informed consent. Exclusion Criteria: 1. Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy. 2. Have other malignancies within the past 5 years. 3. Presence with uncontrollable third space effusion. 4. Have undergone other anti-tumor treatment within 4 weeks before the first dose. 5. A history of immunodeficiency. 6. Clinically significant cardiovascular diseases. 7. Known or suspected interstitial lung disease. 8. Known hereditary or acquired bleeding tendency. 9. Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1. 10. Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products. 11. Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer are added.
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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
2 sites. 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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Cancer Hospital，Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Peking University Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China