Recruiting NCT07551050
Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: TNBC - Triple-Negative Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Primary outcome measures
- Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score. [Time frame: 12 weeks]
Secondary outcome measures (5)
- Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration. [Time frame: 12 weeks]
- Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score. [Time frame: 12 weeks]
- Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up. [Time frame: 12 weeks]
- PFS [Time frame: 6 weeks]
- OS [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07551050 · SCRPC-01