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New drug aims to outperform standard therapy in High-Risk breast cancer

NCT ID NCT06126640

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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.

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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.

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