Evaluating SHR-A1811 with or without Pertuzumab for HER2-Positive 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
This study is testing a new injection called SHR-A1811, both alone and with another drug, to see if it works better than the standard treatment for women with HER2-positive breast cancer that has come back or spread.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 864 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | pertuzumab, trastuzumab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06057610 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of SHR-A1811 injection, both alone and in combination with pertuzumab, compared to the standard treatment of trastuzumab, pertuzumab, and docetaxel in patients with HER2-positive recurrent or metastatic breast cancer. The study will involve women aged 18 to 75 who have confirmed HER2-positive breast cancer and meet specific health criteria. Participants will be monitored for treatment outcomes and side effects to determine the potential benefits of the new treatment regimen.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 75 with unresectable or metastatic HER2-positive breast cancer.
Not a fit: Patients with active central nervous system metastasis or those who have had other malignancies within the past 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with HER2-positive recurrent or metastatic breast cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches in treating HER2-positive breast cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Qi Zhang
- Email: qi.zhang@hengrui.com
- Phone: +0518-81220121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.