HER2+ early breast cancer
Conditions
Interventions
Group of HER2+ early breast cancer:NA
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: = 18 years at the time of enrollment into the study Women Have signed the informed consent form as per local regulations Newly diagnosed with non-metastatic breast cancer (stage I-II-III, HER2+) at the time of starting anti-HER2 therapy Be able to comply with the follow-up visits, assessments, answering questionnaires
Exclusion criteria
Exclusion criteria: Metastatic breast cancer Prior systemic treatment for any malignancy Active secondary cancer requiring anti-HER2 therapy 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 Men
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EORTC QLQ-C30 score: Includes scores for all 30 questions (items) and date of self-assessment at T0 to T3; | — |
Secondary
| Measure | Time frame |
|---|---|
| EORTC QLQ-C30 score;PDQ-5 score: includes scores for all 5 items and date of self-assessment at T0 to T3;PHQ-9 score: includes scores for all 9 items and date of self-assessment at T0 to T3;GAD-7 score: includes scores for all 7 items and date of self-assessment at T0 to T3;ISI score: includes scores for all 7 items and date of self-assessment at T0 to T3;TASQ-SC score: includes scores for all 12 items and date of self-assessment at T3; | — |
Countries
China
Contacts
Public ContactKeda Yu
Fudan University Shanghai Cancer Center
Outcome results
None listed