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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05122377
Other study ID # 2021-40-2343
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2021
Est. completion date April 2024

Study information

Verified date November 2021
Source Fudan University
Contact Lei Fan
Phone +86 15821358688
Email teddyfl@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date April 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
3M GnRHa
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).
1M GnRHa
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).

Locations

Country Name City State
China Fudan University Shanghai Cancer Center Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
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