Comparing SHR-A1811 to standard chemotherapy for advanced breast cancer

A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer

This study is testing a new treatment called SHR-A1811 to see if it works better than standard chemotherapy for people with advanced breast cancer that has low levels of HER2.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 530 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05814354 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of SHR-A1811 compared to investigator-selected chemotherapy in patients with HER2-low recurrent or metastatic breast cancer. The study focuses on measuring progression-free survival as the primary outcome. Eligible participants must have low-HER2 expression and have experienced disease progression after at least one endocrine therapy. The trial will involve administering SHR-A1811 alongside various chemotherapy agents such as Capecitabine and Eribulin.

Who should consider this trial

Good fit: Ideal candidates include women with low-HER2 expression breast cancer who have progressed after endocrine therapy and have received limited prior chemotherapy.

Not a fit: Patients with known active central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with HER2-low recurrent or metastatic breast cancer.

How similar studies have performed: While there have been studies on HER2-targeted therapies, the specific approach of SHR-A1811 in this context is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Shouwei Zhao

Conditions: Breast Cancer