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

NCT07180914 | Not Yet Recruiting DMC

• 1 other identifier: IRB-2025-977
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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. 1.What are the rates of compliance with and reasons for discontinuation of adjuvant OFS endocrine therapy?
2. 2.What is the impact of OFS treatment duration on patient prognosis?

Conditions

Breast Cancer Females

Keywords

OFS; Hormone receptor positive; Early-stage breast cancer

Outcome Measures

Primary Outcomes (1)

• Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation.

  The proportion of patients who discontinue OFS within 2 years.

  Follow-up will be conducted every 3 months during the period from baseline to 2 years of endocrine therapy.

Secondary Outcomes (4)

• Effect of OFS Treatment Duration on Prognosis.

  3-year iDFS rate for OFS treatment duration ≥2 years and <2 years

• 3-year iDFS for Different OFS Combination Regimens.

  3 years.

• 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

• 3-year iDFS of different subgroups

  3 years

Study Arms (1)

Early-stage HR-positive premenopausal breast cancer patients receiving OFS treatment.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Female breast cancer patients who were premenopausal at the time of surgery. 2. Newly diagnosed patients with invasive breast cancer, TNM stage I-III. 3. HR-positive (defined as ER ≥ 10% and/or 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. 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.

You may qualify if:

• 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.

You may not qualify if:

• Simultaneously participating in another blinded clinical study.
• Presence of other active malignant tumors or multiple primary cancers.
• Pregnant or lactating women.
• 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).

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• Beijing Health Promotion Association: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yang Yu

CONTACT

+8613958013303; yuyangkaiyu@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09