Breast cancer
Conditions
Interventions
OFS plus aromatase inhibitor (OFS+AI) group:None
OFS plus tamoxifen (OFS+TAM) group:None
Sponsors
Women's Hospital School of Medicine Zhejiang University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Female, aged 18–45 years; (2) Histopathologically confirmed invasive breast cancer; (3) Hormone receptor–positive (ER and/or PR positive); (4) Premenopausal status (baseline FSH 20 pg/mL); (5) Planned to receive OFS in combination with endocrine therapy; (6) No GSM-related symptoms prior to initiation of treatment; (7) Provision of written informed consent.
Exclusion criteria
Exclusion criteria: (1) Concomitant malignancies; (2) Severe cardiac, hepatic, or renal dysfunction; (3) Pregnancy or lactation; (4) History of vaginal infections; (5) Use of antibiotics or hormonal medications within the past 3 months; (6) Expected survival time < 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vaginal microbial diversity and the relative abundance of Lactobacillus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal Health Index (VHI);Visual analogue scale (VAS) score for GSM symptoms; | — |
Countries
China
Contacts
Public ContactFang Wan
Women's Hospital School of Medicine Zhejiang University
Outcome results
None listed