Compliance of OFS Therapy in HR+ Premenopausal Breast Cancer
Data Collection
Collected from today forward - ProspectiveBreast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: October 10, 2025
Actual date on which the first participant was enrolled.The study is focused on understanding how well premenopausal women with early-stage hormone receptor-positive breast cancer adhere to a specific type of hormone therapy called OFS, or ovarian function suppression. The research aims to identify why some patients may stop taking this therapy and to see how the length of time they remain on it affects their health outcomes. This study is important because it seeks to improve the management of breast cancer treatment by ensuring patients receive the most effective care over time. By examining real-world cases, the study hopes to address challenges faced by these patients and potentially improve their long-term health. Participants in this study are not required to undergo any new treatments as part of the research. Instead, their existing treatment records and experiences are being reviewed to gather data. The study collects information about their demographics, breast cancer diagnosis, other health conditions, past medical history, current treatment status, and any side effects they experience. This information helps researchers understand the treatment's adherence levels and its impact on outcomes. The study is being conducted at multiple centers, aiming to gather comprehensive data from about 300 patients, which will help in drawing meaningful conclusions about the therapy's effectiveness and patient compliance in real-world settings.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Female breast cancer patients who were premenopausal at the time of surgery. 2. Newly diagnosed patients with invasive breast cancer, tumor node metastasis(TNM) stage I-III. 3. HR-positive (defined as ER ≥ 10% and/or progesterone receptor(PR) ≥ 10%). 4. Patients who have undergone radical mastectomy and are planning to receive OFS treatment. 5. Have received (neo)adjuvant chemotherapy and radiotherapy. 6. Eastern Cooperative Oncology Group Performance Status(ECOG PS) score of 0-1. 7. Complete medical records. 8. Willing to accept long-term follow-up. 9. Any adverse events that occurred during adjuvant chemotherapy (if applicable) have recovered or decreased to grade 1 (according to CTCAE v5.0) at the start of OFS treatment. Exclusion Criteria: 1. Simultaneously participating in another blinded clinical study. 2. Presence of other active malignant tumors or multiple primary cancers. 3. Pregnant or lactating women. 4. Other conditions that the investigator deems unsuitable for inclusion in the study. 5. Planning to use systemic therapies not described in the study cohort during the endocrine therapy phase (such as, but not limited to, chemotherapy, Antibody-Drug Conjugates(ADCs), or immunotherapy).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives