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

NCT06784921 | Recruiting

• 1 other identifier: IRB-2023-1203
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Metastatic

Keywords

Breast cancer; Sacituzumab Govitecan

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-Free Survival

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

Secondary Outcomes (3)

• Objective Response Rate

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

• DoR

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

• OS

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

Other Outcomes (1)

• adverse event

  from enrollment to 30 days after the last dose administrate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient had a diagnosis of metastatic breast cancer, received at least two cycles of sacituzumab govitecan.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collect puncture tissue specimens before and after drug use for proteomics detection.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiaojia Wang, MD; Ph.D

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Qin Wu, Ph.D

  Hangzhou Institute of Medicine (HIM)

  PRINCIPAL INVESTIGATOR

• Huanhuan Zhou, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojia Wang, PhD

CONTACT

13906500190; wxiaojia0803@163.com

Huanhuan ZHOU, MD

CONTACT

zhhuan77@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 20, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-01

Locations

CN (1)