Real-world Study of Sacituzumab Govitecan Monotherapy or Combination Therapy in Recurrent or Meta… (NCT07018427) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Real-world Study of Sacituzumab Govitecan Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
China70 participantsStarted 2023-05-01
Plain-language summary
This multicenter observational real-world study is planned to enroll 100 patients, divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/HER2- BC) cohort. The study aims to evaluate the efficacy and safety of sacituzumab govetican (SG) monotherapy or combination regimens in patients with unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer within a real-world context.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age and Gender Male or female aged 18 years or older.
✓. Pathological Diagnosis and Classification Criteria (Must Meet Either Cohort Condition) 2.1 Triple-Negative Breast Cancer (TNBC) Cohort
✓.2 Hormone Receptor-Positive/HER2-Negative Breast Cancer (HR+/HER2- BC) Cohort
✓. Treatment Protocol Requirements Planned to receive SG monotherapy or combination therapy.
✓. Other Enrollment Criteria Willing to participate in the study, sign the informed consent form, and demonstrate good compliance.
Exclusion criteria
✕. Pregnant or lactating women.
✕. Known allergy to sacituzumab govitecan (SG) or any of its components.
✕. History of other malignancies, except the following:
✕. Diagnosis of other malignancies within the past 5 years
✕
What they're measuring
1
Real world progression free survival (rwPFS)
Timeframe: 12 months after the last patient was enrolled
Trial details
NCT IDNCT07018427
SponsorPeking University Cancer Hospital & Institute
. Current participation in other interventional clinical studies.
✕. Presence of acute or chronic infections, or coexisting serious diseases (such as decompensated heart, lung, liver, or renal failure), assessed by investigators as incompatible with tolerating the study treatment.
✕. Mental illness or psychiatric disorders leading to poor compliance, inability to cooperate with the study, or inability to describe treatment responses.
✕. Modification of the treatment regimen after SG administration for reasons other than disease progression.