Clinical trial NCT06798506: Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Triple-negative Breast Cancer
Official 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: TNBC - Triple-Negative Breast Cancer
Keywords: Sacituzumab Govitecan
chemotherapy
metastatic breast cancer
TNBC
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients aged over 18 years old.
2. 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.
3. 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.
4. Patients who have received at least 1 prior regimen in the metastatic setting.
5. Plan to receive or has received sacituzumab govitecan monotherapy or chemotherapy of the physician's choice.
6. Available medical history.
7. All patients can provide an informed consent before enrolment and data collection.

Exclusion Criteria:

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

Primary outcomes:
measure: Patient-reported HRQOL
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient-reported functioning
timeFrame: 6 weeks
measure: Patient-reported symptoms
timeFrame: 6 weeks
measure: Patient-reported tolerability
timeFrame: 6 weeks
measure: PFS
timeFrame: 6 weeks
measure: ORR
timeFrame: 6 weeks
measure: CBR
timeFrame: 6 weeks
measure: OS
timeFrame: 6 weeks
measure: Safety
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: