A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-posit… (NCT07180914) | Clinical Trial Compass
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A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer
300 participantsStarted 2025-10-10
Plain-language summary
The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer. The study also aims to understand the compliance with and reasons for discontinuing adjuvant OFS endocrine therapy under different combination regimens.
The main questions it aims to answer are:
1. What are the rates of compliance with and reasons for discontinuation of adjuvant OFS endocrine therapy?
2. What is the impact of OFS treatment duration on patient prognosis?
Participants, who are already receiving OFS treatment as part of their regular medical care, will have their demographic data, treatment status, clinical outcomes, and adverse events collected over time.
Who can participate
SexFEMALE
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Inclusion criteria
✓. Female breast cancer patients who were premenopausal at the time of surgery.
✓. Newly diagnosed patients with invasive breast cancer, tumor node metastasis(TNM) stage I-III.
✓. HR-positive (defined as ER ≥ 10% and/or progesterone receptor(PR) ≥ 10%).
✓. Patients who have undergone radical mastectomy and are planning to receive OFS treatment.
✓. Have received (neo)adjuvant chemotherapy and radiotherapy.
✓. Eastern Cooperative Oncology Group Performance Status(ECOG PS) score of 0-1.
✓. Complete medical records.
✓. Willing to accept long-term follow-up.
Exclusion criteria
✕. Simultaneously participating in another blinded clinical study.
✕. Presence of other active malignant tumors or multiple primary cancers.
✕. Pregnant or lactating women.
✕
What they're measuring
1
Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation.
Timeframe: Follow-up will be conducted every 3 months during the period from baseline to 2 years of endocrine therapy.
. Other conditions that the investigator deems unsuitable for inclusion in the study.
✕. 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).