Clinical trial · Observational
A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer
A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for HR+ Premenopausal Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Females | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Early-stage HR-positive premenopausal breast cancer patients receiving OFS treatment.
Primary outcomes (1)
- measure
- 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.
- description
- The proportion of patients who discontinue OFS within 2 years.
Secondary outcomes (4)
- measure
- Effect of OFS Treatment Duration on Prognosis.
- timeFrame
- 3-year iDFS rate for OFS treatment duration ≥2 years and <2 years
- description
- To observe the effect of OFS treatment duration on prognosis.
- measure
- 3-year iDFS for Different OFS Combination Regimens.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available