Status:
NOT_YET_RECRUITING
A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Collaborating Sponsors:
Beijing Health Promotion Association
Conditions:
Breast Cancer Females
Eligibility:
FEMALE
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 rea...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07180914
Start Date
October 10 2025
End Date
December 31 2029
Last Update
September 18 2025
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