A Real World Study of Sacituzumab Govitecan

NCT06966141 | Recruiting

• 1 other identifier: WONDER
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer Metastatic; Treatment Outcome

Outcome Measures

Primary Outcomes (2)

• 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.

  Six months after the last patient was enrolled

• 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.

  Up to approximately 12 weeks

Study Arms (1)

Patients received SG

HER2-negative breast cancer patients who received SG in the advanced stage

Eligibility Criteria

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

Study Population

HER-2 negative Breast Cancer Patients received SG

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Jian Zhang, MD,PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhang, MD,PhD

CONTACT

+8664175590; syner2000@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: August 12, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

CN (1)