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

A Real-world, Multicenter, Prospective Study to Evaluate the Patient-reported Outcome in Chinese Patients Who Received Sacituzumab Govitecan or Chemotherapy of the Physician's Choice for Metastatic Triple-negative Breast Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: TNBC - Triple-Negative Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Biyun Wang, Professor; Phone Number: +86 13701748410; Email: pro_wangbiyun@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
      • Contact: Biyun Wang; Phone Number: +86 18017312387; Email: pro_wangbiyun@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sacituzumab Govitecan cohort
Chemotherapy of the physician's choice cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported HRQOL	Patient-reported health-related quality of life (HRQOL) evaluated by EORTC QLQ-C30 questionnaires	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression free survival	6 weeks
ORR	Overall Response Rate	6 weeks
CBR	Clinical benefit Rates	6 weeks
OS	Overall Survival	6 weeks
Patient-reported functioning	Patient-reported functioning evaluated by QLQ-BR45 questionnaires.	6 weeks
Patient-reported symptoms	Treatment-related symptoms were assessed using the Patient-Reported Outcomes of the PRO-CTCAE.	6 weeks
Patient-reported tolerability	Treatment-related tolerability were assessed using the Patient-Reported Outcomes of the PGI-TT questionnaires.	6 weeks
Safety	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	6 weeks

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: chemotherapy; TNBC; metastatic breast cancer; Sacituzumab Govitecan
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: YOUNGBC-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No