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

NCT07551050 | Recruiting

• 1 other identifier: SCRPC-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

TNBC - Triple-Negative Breast Cancer

Keywords

Sacituzumab Govitecan; chemotherapy; metastatic breast cancer; TNBC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  12 weeks

• Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up.

  12 weeks

• PFS

  6 weeks

• OS

  6 weeks

Study Arms (2)

Sacituzumab Govitecan

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TNBC

You may qualify if:

• Patients aged 18 to 75 years.
• 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.
• 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.
• ECOG-PS ≤2
• 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.
• At least one evaluable lesion by CT or MRI according to RECIST 1.1.
• Willing to accept the treatment by the investigator based on the patient's preference, physical condition, prior treatment history, and financial circumstances.
• Willing to use contraceptive measures during the study period.
• Willing and able to complete electronic questionnaires/scales on a smartphone, tablet, or other electronic device.
• All patients can provide an informed consent before enrolment and data collection.

You may not qualify if:

• 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.
• History of other malignancies or hematologic malignancies.
• Hypersensitivity to the study treatment drugs.
• Systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study drug administration.
• Treatment with an investigational product within 4 weeks before the first treatment.
• Presence of any toxicity from prior therapy (excluding alopecia) ≥ Grade 2 according to CTCAE version 5.0, prior to study drug administration.
• 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.
• 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.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

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: April 20, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): June 15, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)