Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic 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 Breast Cancer Progressing on First-line Treatment

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 breast cancer progressing on first-line treatment

Study Overview

• Status: 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 Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • 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

TNBC

Description

Inclusion Criteria:

1. Patients aged 18 to 75 years.
2. Patients have been diagnosed with metastatic HER2 negative breast cancer. HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. 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. ECOG-PS ≤2
5. For patients with triple-negative breast cancer (TNBC): at least 1 line of systemic therapy in the metastatic setting; for patients with HR+/HER2- breast cancer: prior treatment with endocrine therapy and CDK4/6 inhibitors, and at least 1 line of systemic therapy in the metastatic setting.
6. At least one evaluable lesion by CT or MRI according to RECIST 1.1.
7. Willing to accept the treatment by the investigator based on the patient's preference, physical condition, prior treatment history, and financial circumstances.
8. Willing to use contraceptive measures during the study period.
9. Willing and able to complete electronic questionnaires/scales on a smartphone, tablet, or other electronic device.
10. All patients can provide an informed consent before enrolment and data collection.

Exclusion Criteria:

1. Insufficient bone marrow, hepatic, or renal function, defined as:

   • Bone marrow: White blood cell count < 3.0 × 10⁹/L, or absolute neutrophil count < 1.5 × 10⁹/L, or platelet count < 75 × 10⁹/L, or hemoglobin < 8.0 g/dL.
   • Hepatic function: Total bilirubin > 1.5 × upper limit of normal (ULN), or ALT/AST > 3.0 × ULN (or > 5.0 × ULN in the presence of liver metastases).
   • Renal function: Serum creatinine > 1.5 × ULN, or creatinine clearance < 50 mL/min.
2. History of other malignancies or hematologic malignancies.
3. Hypersensitivity to the study treatment drugs.
4. Systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study drug administration.
5. Treatment with an investigational product within 4 weeks before the first treatment.
6. Presence of any toxicity from prior therapy (excluding alopecia) ≥ Grade 2 according to CTCAE version 5.0, prior to study drug administration.
7. Systemic inflammatory diseases, including but not limited to systemic lupus erythematosus, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or active vasculitis.
8. Severe psychiatric or neurological disorders, including but not limited to schizophrenia, depression, mania, Alzheimer's disease, myasthenia gravis, seizure disorders, or known conditions that may provoke seizures.
9. Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sacituzumab Govitecan
Chemotherapy of the physician's choice; Chemotherapy of the physician's choice, including single-agent or combination chemotherapy regimens consisting of commonly used chemotherapeutic drugs for breast cancer, such as taxanes, anthracyclines, vinorelbine, gemcitabine, capecitabine, eribulin, and cisplatin/carboplatin. Combination with other targeted therapies, including immune checkpoint inhibitors (PD-1/PD-L1 monoclonal antibodies) and bevacizumab, is also permitted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.	Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression free survival	6 weeks
OS	Overall Survival	6 weeks
Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration.	Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration.	12 weeks
Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score.	Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score.	12 weeks
Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up.	Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up.	12 weeks

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): June 15, 2029

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

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; Skin and Connective Tissue Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: SCRPC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No