Breast Cancer Female, Endocrine Therapy
Conditions
Keywords
ovarian function suppression, Hormone receptor (HR) positive, HER2 negative, early breast cancer, prolonged therapy
Brief summary
To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS. This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.
Interventions
DRUGOFS continues to use group after 5 years use
Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use.
DIAGNOSTIC_TESTImmunohistochemical detection of HR status
Enrolled patients must be HR-positive premenopausal breast cancer patients
Sponsors
Hongmei Zheng, PhD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with early primary breast cancer * Female aged 18-60 years (including 18 year and 60 year) * Hormone receptor (HR) positive HER2 negative * Receive 5 years of OFS treatment * ECOG score 0-1 * Voluntarily join this study and sign the informed consent form; * The researcher believes that it can benefit.
Exclusion criteria
* The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years * Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision * Invasive metastases with known obvious symptoms * Invasive metastases with known obvious symptoms * Doctors think it is not suitable for inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| invasive disease-free survival | 5 years | The main effect evaluation index was invasive disease-free survival (iDFS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | Overall survival for years, which means the rate of patients alive in the whole patients at the same group will be calculated with kaplan meier survival curves. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score | 5 years | Quality of life score was evaluated by European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3 (EORTC-QLQ-C30 V3), which conduct a series of questions about the patients' physical condition, activity of daily life, adverse reaction and mood condition. The range in the questionnaire for the score is from 1 to 4, in which 1 stands for having no discomfort and 4 stands for having great discomfort. |
Countries
China
Contacts
Primary ContactHongmei Zheng, Doctor
Backup ContactXinhong Wu, Doctor
Outcome results
None listed