Patient-reported outcomes of sacituzumab govitecan versus physician‑choice chemotherapy in Chinese metastatic HER2‑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 Breast Cancer Progressing on First-line Treatment

This project will test whether sacituzumab govitecan or physician‑choice chemotherapy leads to better patient‑reported quality of life and symptoms for Chinese adults aged 18–75 with metastatic HER2‑negative breast cancer who progressed after first‑line treatment.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, sacituzumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07551050 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, real‑world observational study collects patient‑reported outcomes from Chinese adults with metastatic HER2‑negative breast cancer who receive either sacituzumab govitecan or physician‑choice chemotherapy after progression on first‑line therapy. Eligibility includes age 18–75, locally confirmed HER2‑negative disease, ECOG ≤2, at least one measurable lesion per RECIST 1.1, and prior systemic therapy requirements that differ by subtype (TNBC vs HR+/HER2‑). Treatment decisions are made by the treating physician and the study captures quality of life, symptom burden, and other patient‑reported measures over follow‑up using validated questionnaires. Data will be analyzed to compare real‑world tolerability and patient experience between sacituzumab govitecan and standard chemotherapy options in a Chinese clinical setting.

Who should consider this trial

Good fit: Chinese adults aged 18–75 with metastatic HER2‑negative breast cancer (including TNBC), ECOG performance status 0–2, at least one measurable lesion, and prior first‑line systemic therapy are the ideal candidates.

Not a fit: Patients with HER2‑positive disease, those outside the 18–75 age range, with ECOG >2, or those unable/unwilling to complete patient‑reported questionnaires are unlikely to benefit from participation.

Why it matters

Potential benefit: If positive, the results could help patients and doctors choose treatments that offer better quality of life and symptom control in Chinese metastatic HER2‑negative breast cancer.

How similar studies have performed: Sacituzumab govitecan has demonstrated clinical benefit in randomized trials for metastatic TNBC (for example the ASCENT trial), but real‑world patient‑reported outcome data, especially in Chinese populations, remain limited.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Biyun Wang Professor

Conditions TNBC - Triple-Negative Breast Cancer; Sacituzumab Govitecan; chemotherapy; metastatic breast cancer; TNBC