Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062811) titled 'Treatment Preference Study of Adjuvant Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Early Breast Cancer' on Sept. 3.
Study Type:
Observational
Primary Sponsor:
Institute - Chugai Pharmaceutical Co., Ltd.
Condition:
Condition - Hormone receptor-positive, HER2-negative early breast cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to quantitatively evaluate the factors prioritized by patients during treatment decision-making in adjuvant endocrine therapy for HR+/HER2- early breast cancer in Japan, as well as to describe the implementation of shared decision making in real-world practice.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - Patients with HR-positive, HER2-negative breast cancer
Having history of curative surgery for breast cancer
Currently receiving adjuvant endocrine therapy
Female aged 18 years or older at the time of providing consent
Residing in Japan
Capable of understanding the study and providing informed consent
Having an appropriate device and internet connection to participate in online interviews/surveys
Key exclusion criteria - Having experience with pharmacotherapy for metastatic or recurrent breast cancer
Having history or presence of double cancer other than breast cancer
Current or past employment at a pharmaceutical company, or healthcare professional background for the participant, or current employment at a pharmaceutical company or healthcare professional status for cohabiting family members
Diagnosis of dementia
Participation in the cognitive debriefing interview study for questionnaire validation
Target Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 19 Day
Date of IRB - 2026 Year 08 Month 19 Day
Anticipated trial start date - 2026 Year 09 Month 28 Day
Last follow-up date - 2027 Year 01 Month 05 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071824
Disclaimer: Curated by HT Syndication.