Sacituzumab govitecan for HER2‑negative metastatic breast cancer in China
Official title: 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)
Run by Zhejiang Cancer Hospital · NCT06784921 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | sacituzumab, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT06784921 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Xiaojia Wang, MD; Ph.D — Zhejiang Cancer Hospital
- Study coordinator: Xiaojia Wang, PhD
- Email: wxiaojia0803@163.com
- Phone: 13906500190
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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First-line Sacituzumab Govitecan for Advanced Untreated Triple-Negative Breast Cancer
This study tests whether Sacituzumab Govitecan can slow disease progression when given as a first treatment to adults with advanced triple-negative breast cancer who have not yet received treatment in the advanced setting.
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Observing the effects of Sacituzumab Govitecan in metastatic breast cancer
This study is testing how well Sacituzumab Govitecan works and how safe it is for people with metastatic HER-2 negative breast cancer who have already tried at least two other treatments.
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Preventing neutropenia from sacituzumab govitecan in metastatic triple-negative breast cancer
This trial tests sacituzumab govitecan given with pegfilgrastim to see if it prevents low white blood cell counts in people with metastatic triple-negative breast cancer who have had one or two prior chemotherapy regimens.
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Sacituzumab Tirumotecan plus Pembrolizumab in advanced biliary tract cancer
This study tests whether the combination of Sacituzumab Tirumotecan and Pembrolizumab can help people with advanced biliary tract cancer who have already had at least one approved therapy fail.
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Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion
This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.
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Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer
This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.