New hope for advanced breast cancer: targeted drug combo under trial
NCT ID NCT06057610
First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This phase 3 trial tests a new drug called SHR-A1811, given alone or with pertuzumab, against the standard treatment (trastuzumab, pertuzumab, and docetaxel) in 868 women with HER2-positive breast cancer that has returned or spread. The goal is to see if the new approach can delay cancer growth and improve survival. Participants must be aged 18-75, have measurable tumors, and be in good overall health.
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) with or without pertuzumab
- What this could lead to
- If successful, this could offer a new, more effective treatment option for people with HER2-positive breast cancer that has returned or spread.
- What could go wrong
- This is an early-stage trial, and the new drug may not work better than existing treatments or could have unexpected side effects.
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
-
868 people
The number who actually took part.
- Started
-
Nov 2023
- Expected to finish
-
Oct 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. Women aged 18 to 75 (inclusive) 2. HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology. 3. ECOG score is 0 or 1 4. An expected survival of ≥ 12 weeks 5. At least one measurable lesion according to RECIST v1.1 criteria 6. Have adequate renal and hepatic function 7. Patients voluntarily joined the study and signed informed consent Exclusion Criteria: 1. Have other malignancies within the past 5 years 2. Active central nervous system metastasis without surgery or radiotherapy 3. In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months 4. Presence with uncontrollable third space effusion 5. Have undergone other anti-tumor treatment within 4 weeks before the first dose 6. A history of immune deficiency 7. Clinically significant cardiovascular disorders 8. Known or suspected interstitial lung disease 9. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I 10. Known hereditary or acquired bleeding tendency 11. Active hepatitis and liver cirrhosis 12. Presence of other serious physical or mental diseases or laboratory abnormalities
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HER2-positiverecurrent or metastatic 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
-
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China