A Real World Study of Sacituzumab Govitecan
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFudan University
About this trial
Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 negative Breast Cancer Patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18 or above;
The Eastern Cooperative Oncology Group (ECOG) physical condition score of the United States is ≤2;
Unresectable or metastatic triple-negative breast cancer confirmed by tumor histology or cytology, and having received at least two systemic treatments previously (at least one of which was for metastatic disease); Or HR+/HER2- (IHC 0, 1+ or IHC 2+/ISH-) unresectable or metastatic breast cancer confirmed by tumor histology or cytology, with previous endocrine therapy and ≥2 lines of systemic therapy (for metastatic disease);
Receive gosatetuzumab treatment in the advanced stage;
Disqualifiers
Pregnant or lactating women;
Those with acute or chronic infections, or those with other serious diseases at the same time, are judged by the researchers as unsuitable for this study;
Having suffered from other malignant tumors within 5 years (excluding the following situations: cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; A second primary cancer that has been completely cured and has no recurrence within five years; Researchers have clearly identified which primary tumor source the metastatic foci belong to.
Those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses;
Trial population
HER-2 negative Breast Cancer Patients received SG
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Patients received SG
Trial outcomes
Primary outcomes
1
PFS
PFS was defined as the time interval from the date of DS-8201 initiation until date of progressive disease (PD) or death from any causes, whichever occurred first.
Time frame
Six months after the last patient was enrolled2
ORR
ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame
Up to approximately 12 weeksSponsors and contacts
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Source ClinicalTrials.gov