New drug aims to outperform standard therapy in High-Risk breast cancer
NCT ID NCT06126640
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This phase 3 trial compares a new drug, SHR-A1811, to the standard treatment T-DM1 in women with HER2-positive breast cancer who still have cancer cells after initial therapy. The goal is to see if SHR-A1811 can better prevent the cancer from coming back. Participants receive either drug after surgery, and researchers track how long they remain cancer-free.
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
- What this could lead to
- If SHR-A1811 proves more effective than T-DM1, it could offer a new treatment option to reduce the risk of breast cancer returning in high-risk patients.
- What could go wrong
- This is an early-stage comparison; SHR-A1811 may not outperform T-DM1 or could have unexpected side effects. Results are not guaranteed to change standard care.
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
-
1,615 people
The number who actually took part.
- Started
-
Nov 2023
- Expected to finish
-
Apr 2032
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. The age is 18-75 years old (including both ends), and female 2. HER2 positive invasive breast cancer Confirmed by pathological examination 3. Clinical Stage before Neoadjuvant Therapy was T1-4, N0-3, M0 (excluding T1N0). 4. Residual invasive cancer confirmed by pathological examination after radical surgery must meet one of the following two conditions: * If the clinical stage before neoadjuvant therapy is cT4N0-3M0 or cT1-3N2-3M0, there is residual invasive cancer in the primary breast lesion and/or ipsilateral axillary lymph nodes after surgery. * If the clinical stage before neoadjuvant therapy was cT1-3N0-1M0 (except T1N0), there was residual invasive cancer in the ipsilateral axillary lymph nodes after surgery. 5. Previous neoadjuvant therapy must meet all of the following conditions: * Neoadjuvant chemotherapy: At least 6 treatment cycles, including no less than 9 weeks of taxane-based chemotherapy (anthracycline-containing chemotherapy allowed). * Neoadjuvant anti-HER2 targeted therapy: No less than 9 weeks of targeted therapy including trastuzumab must be completed. 6. Have received radical surgery for breast cancer: 7. The interval from the completion of radical surgery to the first random medication should be at least 3 weeks and no more than 12 weeks. 8. Hormone receptor (HR) status was confirmed by postoperative pathologic examination. HR positive is defined as positive for the estrogen receptor (ER) or progesterone receptor (PR), and HR negative is defined as negative for both ER and PR. 9. The ECOG score is 0 or 1 10. Heart function is good 11. Agree to birth control Exclusion Criteria: 1. Stage IV metastatic breast cancer 2. Evidence of recurrent breast cancer, including local recurrence, regional recurrence and distant metastasis . 3. In the past 5 years, patients suffered from other malignant tumors, excluding cured basal cell carcinoma of skin andcervical carcinoma in situ,. 4. Previously received systemic anti-HER2-ADC drug therapy, including but not limited to trastuzumab emtansine (T-DM1), Trastuzumab Deruxtecan (T-DXd), etc. 5. Previous dosage requirements for anthracycline exposure meet one of the following conditions: * Doxorubicin or anthracyclines with similar exposure equivalent \> 240mg/m2; * Epirubicin or liposomal doxorubicin hydrochloride \> 480mg/m2. 6. History of cardiovascular diseases with clinical significance, such as severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA ≥ Ⅱ), supraventricular or ventricular arrhythmia with clinical significance and requiring treatment or intervention, and myocardial infarction within 6 months. 7. Subjects with known or suspected interstitial pneumonia. 8. Known hereditary or acquired bleeding and thrombosis tendency. 9. History of active hepatitis B, hepatitis C or liver cirrhosis. 10. There were other serious physical or mental diseases or abnormal laboratory examinations that may increase the risk of participating in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HER2-positive primary breast cancer participants with residual invasive disease following neoadjuvant therapy 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, 200030, China
-
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China