A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer

Not yet recruiting

• Conditions: Breast Cancer Females

• Registration Number: NCT07180914
• Lead Sponsor: Zhejiang Cancer Hospital

Brief 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.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-10-10
• Primary Completion: 2029-07-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation.	Follow-up will be conducted every 3 months during the period from baseline to 2 years of endocrine therapy.	The proportion of patients who discontinue OFS within 2 years.

Secondary Outcome Measures

Name	Time	Method
Effect of OFS Treatment Duration on Prognosis.	3-year iDFS rate for OFS treatment duration ≥2 years and <2 years	To observe the effect of OFS treatment duration on prognosis.
3-year iDFS for Different OFS Combination Regimens.	3 years.	3-year iDFS for different OFS combination therapy regimens.
Safety of different combination regimens	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	The collection and analysis of various adverse events and serious adverse events that occur during different treatment processes.
3-year iDFS of different subgroups	3 years	The 3-year invasive disease-free survival (iDFS) for different patient subgroups.