Clinical trial Recruiting at 1 site Observational Ages 18 to 75 Women only

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.

More Breast Cancer Metastatic trials

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexWomen only
Enrollment200 (estimated)
SponsorZhejiang Cancer Hospital
Academic / other
Drugs / interventionssacituzumab, chemotherapy
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedFebruary 1, 2025
Main results expectedDecember 30, 2026
Study endsDecember 30, 2026
Registry record updatedJanuary 16, 2026
Trial IDNCT06784921 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

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.