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NCT Number: NCT06784921

To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Patients in China.

To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.

Recruiting

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Key information

Conditions

Breast Cancer Metastatic Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

This study will conduct a multicenter, open, prospective clinical trial to investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. PFS

    Time frame: from enrollment to progression or death (for any reason),assessed up to 100 months

    Progression-Free Survival

Secondary outcomes

  1. Objective Response Rate

    Time frame: from enrollment to progression or death (for any reason), assessed up to 100 months

    Ratio of CR and PR in all subjects

  2. DoR

    Time frame: The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months

    Duration of Response

  3. OS

    Time frame: from enrollment to death (for any reason).assessed up to 100 months

    Overall Survival

Other outcomes

  1. adverse event

    Time frame: from enrollment to 30 days after the last dose administrate

    Adverse events are described in terms of CTC AE 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Huanhuan ZHOU, MD

CONTACT

[email protected]

Xiaojia Wang, PhD

CONTACT

[email protected]

13906500190

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study 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）

Acronym: SACIT-OUT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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