Combining SHR-A1811 with capecitabine for treating advanced breast cancer with low HER2 expression

An Open-Label, Multi-center Phase Ⅰb/Ⅱ Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.

This study is testing if a new treatment combining SHR-A1811 with capecitabine can help women with advanced breast cancer that has low HER2 levels feel better and improve their health.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 9 sites (Hefei, Anhui and 8 other locations)
• Trial ID: NCT05845138 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of SHR-A1811 in combination with capecitabine for women with unresectable or metastatic breast cancer that has low HER2 expression. The study aims to assess the tolerability, pharmacokinetics, and immunogenicity of this treatment regimen. Participants will be monitored for their response to the therapy and any side effects experienced during the treatment. The trial includes both Phase 1 and Phase 2 evaluations to gather comprehensive data on the intervention's performance.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with confirmed low HER2 expression unresectable or metastatic breast cancer.

Not a fit: Patients with other malignancies within the past 5 years or those who have recently undergone other cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with low HER2 expression breast cancer, potentially improving their outcomes.

How similar studies have performed: While there is ongoing research in this area, the specific combination of SHR-A1811 and capecitabine for low HER2 expression breast cancer is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Women aged 18 to 75 (inclusive).
2. HER2 low expression 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. Women of childbearing potential (WOCBP) subjects must agree to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding.
7. Patients voluntarily joined the study and signed informed consent, had good compliance and willingness to cooperate with the visit and study related procedures.

Exclusion Criteria:

1. Have other malignancies within the past 5 years.
2. Presence with uncontrollable third space effusion.
3. Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication.
4. Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I inhibitor.
5. Clinically significant cardiovascular disorders.
6. Presence of active hepatitis B, hepatitis C, cirrhosis,or serious infected persons requiring antibiotic, antiviral or antifungal control.
7. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
8. Known to be allergic to any study drug or any of its excipients, or to humanized monoclonal antibody products.
9. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption.
10. Presence of other serious physical or mental diseases or laboratory abnormalities.

Where this trial is running

Hefei, Anhui and 8 other locations

• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (NOT_YET_RECRUITING)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijng, China (RECRUITING)
• Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• Shantou Central Hospital — Shantou, Guangzhou, China (NOT_YET_RECRUITING)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (RECRUITING)
• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• Shandong Cancer Hospital&Institute — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Wenzhou People's Hospital — Wenzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Shuchao Wu

Conditions: Breast Cancer