A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-posit… (NCT07180914) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. Simultaneously participating in another blinded clinical study.
. Presence of other active malignant tumors or multiple primary cancers.
. Pregnant or lactating women.
. 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).