Sacituzumab govitecan for HER2‑negative metastatic breast cancer in China

Real-World Patient Characteristics, Treatment Patterns, and Outcomes for Patients With HER2 Negative Metastatic Breast Cancer Treated With Sacituzumab Govitecan: A Retrospective Trial in China（SACIT-OUT）

This will test how well sacituzumab govitecan works and how safe it is for adults in China with HER2‑negative metastatic breast cancer.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Zhejiang Cancer Hospital (Academic / other)
• Drugs / interventions: sacituzumab, chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06784921 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open, prospective observational effort led by Zhejiang Cancer Hospital to collect real‑world efficacy and safety data on sacituzumab govitecan in HER2‑negative metastatic breast cancer. Eligible patients are adults with histologically confirmed HER2‑negative locally recurrent or metastatic disease, ECOG 0–2, measurable lesions by RECIST 1.1, life expectancy ≥12 weeks, and who have received at least two cycles of sacituzumab govitecan. The study will record tumor responses, progression measures, and treatment‑related adverse events using routine clinical assessments. Data will be used to describe outcomes in a Chinese clinical practice setting rather than to compare against a randomized control group.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed HER2‑negative locally recurrent or metastatic breast cancer, ECOG 0–2, at least one measurable lesion, life expectancy ≥12 weeks, and who have received at least two cycles of sacituzumab govitecan are the intended participants.

Not a fit: Patients who are pregnant or breastfeeding, have another recent malignancy, have major neurological or psychiatric disorders, or who have not received at least two cycles of sacituzumab govitecan are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could clarify how effective and tolerable sacituzumab govitecan is for HER2‑negative metastatic breast cancer patients treated in routine care in China.

How similar studies have performed: Prior clinical trials have shown sacituzumab govitecan activity in metastatic triple‑negative and some HER2‑negative breast cancers, but published real‑world data in Chinese patient populations remain limited.

Eligibility criteria

Inclusion Criteria:

Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.

HER2-negative breast cancer(according to 2018 ASCO/CAP HER2 test guideline). 18-75 years old. ECOG PS 0～2. life expectancy is not less than 12 weeks. at least one measurable lesion according to RECIST 1.1. received at least two cycles of SG. Signed informed

Exclusion Criteria:

Patients who did not receive sacituzumab govitecan treatment for two or more cycles Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.

Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial History of neurological or psychiatric disorders Researchers believe that patients are not suitable for any other situation in this study.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Xiaojia Wang, MD; Ph.D — Zhejiang Cancer Hospital
• Study coordinator: Xiaojia Wang, PhD

Conditions Breast Cancer Metastatic; Breast cancer; Sacituzumab Govitecan