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RecruitingNCT06966141Updated May 11, 2025

A Real World Study of Sacituzumab Govitecan

An observational study in Breast Cancer Metastatic and Treatment Outcome, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Breast Cancer Metastatic
  • Treatment Outcome
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

HER-2 negative Breast Cancer Patients received SG

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female aged 18 or above;
  2. The Eastern Cooperative Oncology Group (ECOG) physical condition score of the United States is ≤2;
  3. 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);
  4. Receive gosatetuzumab treatment in the advanced stage;
  5. During the study period, voluntarily abide by this trial protocol and receive regular follow-ups;
  6. 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.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. 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;
  3. 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.
  4. Those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses;
  5. 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;
  6. Patients allergic to gosatetuzumab;
  7. Patients who changed their treatment regimens after gosatetuzumab treatment due to non-disease progression reasons;
  8. The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients received SG

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

06

What researchers measure

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 enrolled

  2. 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 weeks

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06966141
Lead sponsor
Fudan University
Responsible party
Jian Zhang,MD (Professor, Fudan University) — Principal investigator
First posted
May 11, 2025
Start date
Aug 12, 2024
Primary completion
Aug 1, 2026 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
May 11, 2025

Study contacts

Jian Zhang, MD,PhD
Contact
syner2000@163.com
+8664175590 ext. 85000
Jian Zhang, MD,PhD
principal investigator · Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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