Clinical trial · Observational
RWE About QOL and Compliance of Patients With OFS in China
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
NCT05122377CI-TRIAL-00100240completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hormone Receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1M GnRHa | Drug | — | UNRESOLVED |
| 3M GnRHa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- GnRHa 3-month
- description
- Patients using GnRHa 3-month depot
- interventionNames
- Drug: 3M GnRHa
- label
- GnRHa 1-month
- description
- Patients using GnRHa 1-month depot
- interventionNames
- Drug: 1M GnRHa
Primary outcomes (2)
- measure
- Quality of life (QOL)
- timeFrame
- Change will be assessed over two time points (baseline and 3 months)
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.