RecruitingNCT06966141

A Real World Study of Sacituzumab Govitecan

A Real World Study: Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 Negative Breast Cancer Patients

Sponsor

Fudan University

Enrollment

100 participants

Start Date

Aug 12, 2024

Study Type

OBSERVATIONAL

Conditions

Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 negative Breast Cancer Patients

Min Age: 18 Years

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;
During the study period, voluntarily abide by this trial protocol and receive regular follow-ups;
All women of childbearing age, fertile men or their spouses who have no plans for fertility or sperm donation throughout the trial period until 6 months after the last dose, or who voluntarily take effective contraceptive measures.

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;
Those with severe organic diseases or major organ failure, such as decompensated heart, lung, liver or kidney failure, which makes them unable to tolerate treatment;
Patients allergic to gosatetuzumab;
Patients who changed their treatment regimens after gosatetuzumab treatment due to non-disease progression reasons;
The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study.