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Recruiting

NCT Number: NCT06966141

A Real World Study of Sacituzumab Govitecan

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Jian Zhang, MD,PhD

CONTACT

[email protected]

+8664175590 ext. 85000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. PFS

    Time frame: Six months after the last patient was enrolled

    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.

  2. ORR

    Time frame: Up to approximately 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Zhang, MD,PhD

CONTACT

[email protected]

+8664175590 ext. 85000

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 11, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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