Clinical trial · Observational
Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
Real World Patient-Reported Outcomes in Chinese Her2+ Early Breast Cancer Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
NCT06161922CI-TRIAL-00117130completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a non-interventional observational, multi-center cohort study to evaluate patient-reported outcomes in Chinese HER2+ early breast cancer patients undergoing (neo) adjuvant anti-HER2 based therapy and describe changes over time, from baseline to 12 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- EORTC QLQ-C30 Summary Score
- timeFrame
- Through study completion, an average of 1 year.
- description
- EORTC QLQ C30 questionnaire to evaluate quality of life. The EORTC QLQ-C30 is a 30-item questionnaire consisting of five multi-item functional subscales (physical, role, cognitive, emotional, and social), three multi-item symptom subscales (fatigue, pain, nausea and vomiting), and six single-item symptom subscales (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), in addition to a two-item subscale for global health status. After linear transformation, all subscales range in score from 0-100. The EORTC QLQ-C30 summary score was calculated from the mean of 13 component subscales, excluding global health status and financial difficulties, if all 13 included subscales are non-missing. Prior to calculating the mean, symptom subscales were reversed to obtain a consistent direction for all subscales. Therefore, a higher summary score indicates higher HRQoL.
Secondary outcomes (6)
- measure
- EORTC QLQ-C30
- timeFrame
- Through study completion, an average of 1 year.
- description
- Beyond the summary score, the 15 specific subscales of EORTC QLQ-C30 were analyzed to identify changes in quality of life. For functional subscales and global health status, higher scores reflect superior health status, whereas for symptom subscales, higher scores reflect greater symptom severity.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged ≥18 years; 2. Women; 3. Have signed the informed consent form as per local regulations; 4. Newly diagnosed with non-metastatic breast cancer (stage I-II-III, HER2+) at the time of starting anti-HER2 therapy; 5. Be able to comply with the follow-up visits, assessments, answering questionnaires. Exclusion Criteria: 1. Metastatic breast cancer; 2. Prior systemic treatment for any malignancy; 3. Active secondary cancer requiring anti-HER2 therapy; 4. Vulnerable populations \[e.g., decisional impaired (cognitive, psychiatric), terminally ill, prisoners\], or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent; 5. Men.
References
Publications (0)
Data not yet available
No reference posted for this study.