A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer Females. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for HR+ Premenopausal Breast Cancer
Overview
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.
Detailed description
This real-world non-interventional prospective study aims to explore the compliance and reasons for discontinuation of adjuvant OFS endocrine therapy in early HR-positive premenopausal breast cancer patients under different combination regimens of adjuvant endocrine drugs, as well as to observe the impact of the duration of OFS treatment on prognosis. This study adopts a multi-center, prospective, non-interventional design to collect approximately 300 cases of early HR-positive premenopausal breast cancer patients who received OFS treatment. After obtaining informed consent, the demographic data, breast cancer diagnosis information, comorbidities, past medical history, treatment status, clinical outcomes, and adverse events of the patients were collected. The patients were administered medication in accordance with the standard clinical drug protocols and completed follow-up according to the follow-up plan.
Primary outcome measures
- Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation. [Time frame: Follow-up will be conducted every 3 months during the period from baseline to 2 years of endocrine therapy.]
Secondary outcome measures (4)
- Effect of OFS Treatment Duration on Prognosis. [Time frame: 3-year iDFS rate for OFS treatment duration ≥2 years and <2 years]
- 3-year iDFS for Different OFS Combination Regimens. [Time frame: 3 years.]
- Safety of different combination regimens [Time frame: During the follow-up period, which is every 3 months within the first 2 years, and every 6 months from year 2 to year 3]
- 3-year iDFS of different subgroups [Time frame: 3 years]
Eligibility criteria
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.
- 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
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07180914 · IRB-2025-977