NCT06057610Active, not recruitingPhase 3
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 868 (actual)
- First submitted
- 11 Sept 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 15 Jul 2026
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06057610
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 868
- From 1 Nov 2023 to the primary completion date, 15 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active central nervous system metastasis without surgery or radiotherapy
- In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months
- Have undergone other anti-tumor treatment within 4 weeks before the first dose
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
Other illness
- Have other malignancies within the past 5 years
- A history of immune deficiency
- Clinically significant cardiovascular disorders
- Known or suspected interstitial lung disease
- Known hereditary or acquired bleeding tendency
- Active hepatitis and liver cirrhosis
Lab values
- Presence of other serious physical or mental diseases or laboratory abnormalities
Other
- Presence with uncontrollable third space effusion
Who the study is looking for
- Women aged 18 to 75 (inclusive)
- HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology.
- ECOG score is 0 or 1
- An expected survival of ≥ 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
- Have adequate renal and hepatic function
- Patients voluntarily joined the study and signed informed consent
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.