RWE About QOL and Compliance of Patients With OFS in China

November 15, 2021 updated by: Zhimin Shao, Fudan University

QoL and Treatment Compliance for Pre-menopausal Patients With HR+ Breast Cancer Using GnRHa as Ovarian Function Suppression(OFS) Treatment in the Chinese Population: a Real-world Observational Investigation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premenopausal patients with histologically confirmed primary breast cancer with OFS treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GnRHa 3-month
Patients using GnRHa 3-month depot
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).
Other Names:
  • TAM
  • Leuprorelin 11.25mg dosage
  • AI
GnRHa 1-month
Patients using GnRHa 1-month depot
Drug: 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).
Other Names:
  • TAM
  • AI
  • Leuprorelin 3.75mg dosage
  • Goserelin 3.6mg dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QOL)
Time Frame: 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).
Change will be assessed over two time points (baseline and 3 months)
Treatment compliance
Time Frame: 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).
Change will be assessed over two time points (baseline and 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-40-2343

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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