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NCT07180914Not yet recruiting

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 · Last updated 18 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
12 Sept 2025
Start date
10 Oct 2025
Primary completion date
31 Jul 2029
Lead sponsor
Zhejiang Cancer Hospital
NCT number
NCT07180914

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 10 Oct 2025 to the primary completion date, 31 Jul 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • Presence of other active malignant tumors or multiple primary cancers.
  • Other conditions that the investigator deems unsuitable for inclusion in the study.

Other

  • Simultaneously participating in another blinded clinical study.
  • Pregnant or lactating women.

Who the study is looking for

  • 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.

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.