RWE About QOL and Compliance of Patients With OFS in China

• Conditions: Hormone Receptor-positive Breast Cancer; Breast Cancer; Quality of Life
• Interventions: Drug: 1M GnRHa; Drug: 3M GnRHa

• Registration Number: NCT05122377
• Lead Sponsor: Fudan University

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.

Detailed Description

This was a real world, observational study of adjuvant therapy with GnRHa for OFS in postoperative, premenopausal women with endocrine responsive breast cancer. This trial is designed to compare patients' QOL and treatment compliance measured by FACT-B and self-administered questionnaires during OFS treatment period. Total score of FACT-B and self-administered questionaries, and change from baseline will be calculated and summarized descriptively. Change from baseline will be compared between GnRHa 3-month and GnRHa 1-month using ANCOVA model with baseline value as a covariate.The number depends on the patients who received questionnaire during 18 months recruitment in planned 10 sites. This analytical plan assumes homogeneity across 10 sites so that strata is not considered.

Study Timeline

• Study First Submitted: 2021-10-29
• Status Verified: 2021-11
• Study Start: 2021-11
• Study First Submitted QC: 2021-11-15
• Last Update Submitted: 2021-11-15
• Study First Posted: 2021-11-16
• Last Update Posted: 2021-11-16
• Primary Completion: 2024-02
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Age≥18 years old; Both or either ER+ or PgR+, and human epidermal growth factor receptor type 2 (HER-2)-negative 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.

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Exclusion Criteria

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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GnRHa 1-month	1M GnRHa	Patients using GnRHa 1-month depot
GnRHa 3-month	3M GnRHa	Patients using GnRHa 3-month depot

Primary Outcome Measures

Name	Time	Method
Treatment compliance	Change will be assessed over two time points (baseline and 3 months)	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).
Quality of life (QOL)	Change will be assessed over two time points (baseline and 3 months)	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).

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China