New drug aims to shrink HER2 breast tumors before surgery
NCT ID NCT07196774
First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times
Summary
This phase 3 trial is testing a new drug called SHR-A1811 against a standard chemotherapy combination for women with early-stage or locally advanced HER2-positive breast cancer. About 740 participants will receive either the new drug or standard treatment before surgery. The main goal is to see if the new drug leads to a complete disappearance of cancer in the breast tissue removed during surgery.
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 (an antibody-drug conjugate)
- What this could lead to
- If successful, SHR-A1811 could offer a more targeted, potentially less toxic neoadjuvant option for HER2-positive breast cancer, improving the chance of a complete response before surgery.
- What could go wrong
- This is a phase 3 trial, but results are not yet known. SHR-A1811 may not outperform the standard regimen, and side effects could be similar or different. Long-term benefits like survival are still being followed.
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
-
740 people
The number who actually took part.
- Started
-
Oct 2025
- 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 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. Females treated for the first time, 18-75 years old; 2. ECOG score 0-1; 3. Has pathological diagnosis that meets the criteria: confirmed HER2 positive; 4. Results of laboratory tests meet the enrollment requirements; 5. Pregnancy test result must be negative and must agree to contraception; 6. Has signed the informed consent form. Exclusion Criteria: 1. Confirmed HER2 negative; 2. Has tumor-related medical history or treatment history; 3. Has severe combined disease/medical history and treatment history; 4. Has received treatment with systemic immunostimulants or immunosuppressants; 5. Be allergic to the test drug; 6. Participate in other clinical trials simultaneously; 7. Has received vaccine within 30 days before the first dose; 8. Has received allograft bone marrow transplantation; 9. Has given birth within one year or is breastfeeding; 10. Has history of psychological drug abuse, alcoholism or drug use.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Early-stage or locally advanced HER2-positive breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
-
Shengjing Hospital, China Medical University
Shenyang, Liaoning, 110000, China