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

NCT06798506 | Not Yet Recruiting

• 1 other identifier: YOUNGBC-32
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to explore the real-world patient-reported health-related quality of life (HRQOL), functioning, symptoms and symptom tolerability of sacituzumab govitecan or chemotherapy of the physician's choice for Chinese mTNBC patients. Evaluation of HRQOL and functioning using the EORTC QLQ-C30 and QLQ-BR45 questionnaires, including change from baseline and time to deterioration in each scale or item. Treatment-related symptoms and tolerability were assessed using the Patient-Reported Outcomes of the PRO-CTCAE and PGI-TT questionnaires.

Conditions

TNBC - Triple-Negative Breast Cancer

Keywords

Sacituzumab Govitecan; chemotherapy; metastatic breast cancer; TNBC

Outcome Measures

Primary Outcomes (1)

• Patient-reported HRQOL

  Patient-reported health-related quality of life (HRQOL) evaluated by EORTC QLQ-C30 questionnaires

  6 weeks

Secondary Outcomes (8)

• Patient-reported functioning

  6 weeks

• Patient-reported symptoms

  6 weeks

• Patient-reported tolerability

  6 weeks

• PFS

  6 weeks

• ORR

  6 weeks

Study Arms (2)

Sacituzumab Govitecan cohort

Chemotherapy of the physician's choice cohort

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• Patients aged over 18 years old.
• 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.
• 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.
• Patients who have received at least 1 prior regimen in the metastatic setting.
• Plan to receive or has received sacituzumab govitecan monotherapy or chemotherapy of the physician's choice.
• Available medical history.
• All patients can provide an informed consent before enrolment and data collection.

You may not qualify if:

• If participating in any controlled clinical trial, the subject cannot take part in this study.
• HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
• Pregnancy and lactation.
• Severe hepatic impairment.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Biyun Wang, Professor

CONTACT

+86 13701748410; pro_wangbiyun@163.com

Study Design

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

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 29, 2025
• Study Start: February 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: January 29, 2025

Record last verified: 2024-12

Locations

CN (1)