RWE About QOL and Compliance of Patients With OFS in China

NCT05122377 | Completed FDA Drug

• 1 other identifier: 2021-40-2343
• Study Type: observational
• Target: 562
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the patient's feedback from using GnRHa depot formulation in postoperative, premenopausal patients with hormone receptor-positive breast cancer.

Conditions

Breast Cancer; Quality of Life; Hormone Receptor-positive Breast Cancer

Keywords

GnRHa; patient-reported QoL; treatment compliance

Outcome Measures

Primary Outcomes (2)

• Quality of life (QOL)

  QOL of participant will be measured by Functional Assessment of Cancer Therapy -Breast (FACT-B) questionnaires, a 37-item instrument designed to measure five domains of QOL in breast cancer patients. Score range: 0-148. The score includes forward items (the higher score means the better of quality of life) and the reverse items (the higher score means the worse quality of life).

  Change will be assessed over two time points (baseline and 3 months)

• Treatment compliance

  Treatment compliance will be measured by self-administered questionnaire. Scale score range: 0-40. The score includes forward items (the higher score means the better adherence) and the reverse items (the higher score means the worse adherence).

  Change will be assessed over two time points (baseline and 3 months)

Study Arms (2)

GnRHa 3-month

Patients using GnRHa 3-month depot

Drug: 3M GnRHa

GnRHa 1-month

Patients using GnRHa 1-month depot

Drug: 1M GnRHa

Interventions

3M GnRHa DRUG

This was a real world, observational study of adjuvant endocrine therapy with GnRHa for OFS in postoperative, premenopausal women with endocrine responsive breast cancer. Patients will receive treatment per GnRHa commercial label instruction: leuprorelin, goserelin, leuprorelin from local like: acetate microspheres sustained for injection(boennuokang), leuprorelin acetate microspheres for injection(beiyi).

Also known as: Leuprorelin 11.25mg dosage, TAM, AI

GnRHa 3-month

1M GnRHa DRUG

This was a real world, observational study of adjuvant endocrine therapy with GnRHa for OFS in postoperative, premenopausal women with endocrine responsive breast cancer. Patients will receive treatment per GnRHa commercial label instruction: leuprorelin, goserelin, leuprorelin from local like: acetate microspheres sustained for injection(boennuokang), leuprorelin acetate microspheres for injection(beiyi).

Also known as: Leuprorelin 3.75mg dosage, Goserelin 3.6mg dosage, TAM, AI

GnRHa 1-month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal patients with histologically confirmed primary breast cancer with OFS treatment

You may qualify if:

• Age≥18 years old; Both or either ER+ or PgR+ primary tumor; T1-T3, any N, and M0 according to the TNM classification; Any type of breast surgery (includes breast conserving surgery and breast cancer radical surgery); Any type of preoperative and/or postoperative adjuvant chemotherapy prior to enrollment; History of regular menstruation and not having chemical menopause (FSH≥40 mIU/mL and E2\<10 pg/mL) within 12 weeks after completion of the postoperative chemotherapy; Previously using GnRH-a 1M or 3M as OFS treatment for at least one time; Capable of receiving other study drug like Tamoxifen or AI; Eastern Cooperative Oncology Group performance status of Grade 0 or 1.

You may not qualify if:

• Uncapable of receiving endocrine therapy for any clinical or other reason; Bilateral oophorectomy or ovarian irradiation Inflammatory breast cancer or bilateral breast cancer; Multiple cancers or a history of cancer in other organs; Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent prolonged follow-up.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Patient Compliance

Interventions

Leuprolide; Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Shao

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 16, 2021
• Study Start: March 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

CN (1)