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Can a smart drug outperform chemotherapy for a common breast cancer subtype?

NCT ID NCT05814354

Disease control Sponsor: Jiangsu HengRui Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial is testing whether an experimental drug called SHR-A1811 can slow the growth of HER2-low breast cancer that has returned or spread, compared to standard chemotherapy chosen by the doctor. The study enrolls about 551 adults whose tumors have low levels of HER2, a protein targeted by the drug. Participants are randomly assigned to receive either SHR-A1811 or one of several chemotherapy drugs. The main goal is to see if SHR-A1811 extends the time without the cancer getting worse.

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 experimental antibody-drug conjugate, compared with standard chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel).
What this could lead to
If successful, SHR-A1811 could offer a new, more effective treatment option for people with HER2-low metastatic breast cancer, potentially extending the time before the disease progresses.
What could go wrong
This is a phase III trial, but results are not yet known. The drug may not prove superior to chemotherapy, and antibody-drug conjugates can have side effects like fatigue, nausea, or blood-related issues.

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

551 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Jun 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested). 2. HR-positive breast cancer with at least one endocrine therapy and disease progression was judged by the investigator to no longer benefit from endocrine therapy. 3. Has been treated with 0 to 1 prior lines of chemotherapy in the metastatic setting. 4. Has documented radiologic progression (during or after most recent treatment). 5. Has at least 1 protocol-defined measurable lesion. 6. Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions. 7. Fertile women (WOCBP) subjects agreed to use highly effective contraception and not to breastfeed from the time of study screening until 7 months after receiving the last study medication; a fertile woman must have a negative serum pregnancy test result within 7 days prior to the first treatment. Exclusion Criteria: 1. Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable. 2. A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease. 3. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids. 4. Has moderate or severe cardiovascular disease. 5. Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects. 6. Any other malignancies within 5 years except for those with negligible risk of metastasis or death.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.