Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Triple-negative Breast Cancer

Launched by FUDAN UNIVERSITY · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a treatment called sacituzumab govitecan affects the quality of life for women with metastatic triple-negative breast cancer (TNBC) in China. It aims to understand how patients feel about their health, how well they are able to function in daily life, and what side effects they experience while receiving this treatment compared to standard chemotherapy. To gather this information, participants will fill out questionnaires that ask about their symptoms and overall wellbeing.

To be eligible for this trial, participants must be women over 18 years old who have been diagnosed with metastatic TNBC, meaning their cancer has spread beyond the breast. They should have already received at least one previous treatment for their cancer and be planning to receive either sacituzumab govitecan or another chemotherapy option chosen by their doctor. Those who are pregnant, have severe liver problems, or are participating in other clinical trials cannot join. If you decide to participate, you can expect to share your experiences and health information with researchers to help improve future treatments for TNBC.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged over 18 years old.
• • 2. Patients have been diagnosed with metastatic triple-negative breast cancer (mTNBC). ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. ER-negative and PgR-negative status was defined as≤1% staining in the nuclei by IHC. HER2-negative status was defined by IHC staining 0 to 1+ or fluorescence in situ hybridization ratio \<2.0 if IHC 2+ or IHC not performed.
• • 3. The metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
• • 4. Patients who have received at least 1 prior regimen in the metastatic setting.
• • 5. Plan to receive or has received sacituzumab govitecan monotherapy or chemotherapy of the physician's choice.
• • 6. Available medical history.
• • 7. All patients can provide an informed consent before enrolment and data collection.
• Exclusion Criteria:
• • 1. If participating in any controlled clinical trial, the subject cannot take part in this study.
• • 2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
• • 3. Pregnancy and lactation.
• • 4. Severe hepatic impairment.