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NCT Number: NCT06798506

Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Triple-negative Breast Cancer

The aim of this trial is to explore the real-world patient-reported health-related quality of life (HRQOL), functioning, symptoms and symptom tolerability of sacituzumab govitecan or chemotherapy of the physician's choice for Chinese mTNBC patients. Evaluation of HRQOL and functioning using the EORTC QLQ-C30 and QLQ-BR45 questionnaires, including change from baseline and time to deterioration in each scale or item. Treatment-related symptoms and tolerability were assessed using the Patient-Reported Outcomes of the PRO-CTCAE and PGI-TT questionnaires.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged over 18 years old.
  • Patients have been diagnosed with metastatic triple-negative breast cancer (mTNBC). ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. ER-negative and PgR-negative status was defined as≤1% staining in the nuclei by IHC. HER2-negative status was defined by IHC staining 0 to 1+ or fluorescence in situ hybridization ratio <2.0 if IHC 2+ or IHC not performed.
  • The metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
  • Patients who have received at least 1 prior regimen in the metastatic setting.
  • Plan to receive or has received sacituzumab govitecan monotherapy or chemotherapy of the physician's choice.
  • Available medical history.
  • All patients can provide an informed consent before enrolment and data collection.

Exclusion criteria

  • If participating in any controlled clinical trial, the subject cannot take part in this study.
  • HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
  • Pregnancy and lactation.
  • Severe hepatic impairment.

Treatment and study plan

Primary outcomes

  1. Patient-reported HRQOL

    Time frame: 6 weeks

    Patient-reported health-related quality of life (HRQOL) evaluated by EORTC QLQ-C30 questionnaires

Secondary outcomes

  1. Patient-reported functioning

    Time frame: 6 weeks

    Patient-reported functioning evaluated by QLQ-BR45 questionnaires.

  2. Patient-reported symptoms

    Time frame: 6 weeks

    Treatment-related symptoms were assessed using the Patient-Reported Outcomes of the PRO-CTCAE.

  3. Patient-reported tolerability

    Time frame: 6 weeks

    Treatment-related tolerability were assessed using the Patient-Reported Outcomes of the PGI-TT questionnaires.

  4. PFS

    Time frame: 6 weeks

    Progression free survival

  5. ORR

    Time frame: 6 weeks

    Overall Response Rate

  6. CBR

    Time frame: 6 weeks

    Clinical benefit Rates

  7. OS

    Time frame: 6 weeks

    Overall Survival

  8. Safety

    Time frame: 6 weeks

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Study contacts

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

Biyun Wang, Professor

CONTACT

[email protected]

+86 13701748410

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Real-world, Multicenter, Prospective Study to Evaluate the Patient-reported Outcome in Chinese Patients Who Received Sacituzumab Govitecan or Chemotherapy of the Physician's Choice for Metastatic Triple-negative Breast Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2025
Registry last updated
Jan 29, 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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