Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

This is a non-interventional observational, multi-center cohort study with primary prospective data collection. This study will be conducted at approximately 10 sites in China. The study population is Chinese HER2+ early breast cancer patients receiving (neo) adjuvant anti-HER2 based therapy. Patients who are eligible for (neo) adjuvant anti-HER2 based therapy will enroll in this study. Treatment choice in this non-interventional study will be at the discretion of the treating physician as per CACA-CBCS guidelines. Participants are longitudinally assessed at baseline (T0, before treatment), during chemotherapy (T1, after 2 cycles), 1-month after completion of chemotherapy (T2) and at 12-month follow-up (T3). The PRO instruments will be captured by electronic devices through WeChat mini-program which are input by patients, before or after their clinic visit but before administration of anti-HER2 therapy. Paper questionnaires will be available only as a last option if the electronic devices cannot be used for any reason (such as issues with internet access or if the device is not working). Oncology staff provided no assistance with filling in the questionnaires, but a prerecorded video will provide a detailed explanation of the questionnaires before the ePRO questionnaires. The PROs data will be restored centrally at the server of the leading site. The usage of PROs is considered non-interventional according to local regulation. PRO measures include EORTC QLQ-C30, PDQ-5 (cognitive), PHQ-9 (depression), GAD-7 (anxiety) and Insomnia Severity Index (ISI). Patient satisfaction for subcutaneous injection will be assessed using TASQ-SC at T3. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06161922
Study type Observational
Source Fudan University
Contact Keda Yu, MD, PhD
Phone +8618017317597
Email yukeda@fudan.edu.cn
Status Recruiting
Phase
Start date October 26, 2023
Completion date April 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04095390 - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer Phase 2
Recruiting NCT04578106 - Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy Phase 2
Terminated NCT01912963 - Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer Phase 2
Completed NCT01855828 - Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer Phase 2
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Recruiting NCT04094896 - TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer Phase 2
Recruiting NCT06087120 - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting NCT05346861 - Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab Phase 3
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Completed NCT03330561 - PRS-343 in HER2-Positive Solid Tumors Phase 1
Recruiting NCT04997798 - Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer Phase 2
Not yet recruiting NCT04034823 - KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer Phase 2
Completed NCT04756921 - 18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
Completed NCT03140553 - TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer Phase 2
Completed NCT03094052 - Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib Phase 2
Recruiting NCT05511844 - Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors Phase 1
Recruiting NCT05325632 - Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab Phase 2
Recruiting NCT05710666 - Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study) Phase 2
Not yet recruiting NCT05063643 - Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude
Not yet recruiting NCT03684863 - Capecitabine in HER-2 Positive Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy Phase 2