Phase 3
N=345
Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02518191 ↗Enrolled (actual)
345
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Number of Participants With Premature Ovarian Insufficiency — 10; 38 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GnRHa (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Xiangyun Zong
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Premature Ovarian Insufficiency |
10; 38 | — |
| SECONDARY Survival Rate |
48.17; 49.33 | — |
Summary
This prospective randomized controlled study is conducted to analyze the effect of Goserelin on ovarian function in women with breast cancer in China.
Eligibility Criteria
Inclusion Criteria
- Premenopausal women 18 to 49 years of age are eligible for enrollment
- Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned.
- Eligible participants had taken no estrogens, antiestrogens, selective estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within the month before enrollment.
- Human chorionic gonadotropin negative by urine test before entering the group.
- Informed consent, understanding and compliance with the requirements of the study.
- No significant chronic disease and any organ dysfunction.
Exclusion Criteria
- Exceptions were made for the use of hormonal contraception in women younger than 35 years of age that was discontinued before randomization.
- Use of hormonal treatment for up to 2 months for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes before randomization.
- Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation were excluded.
- Patients received previous adjuvant endocrine therapy for breast cancer are not suitable to this trial.
- Patients with uterine and/or adnexal diseases needing medical or surgical treatment are not suitable.
- Allergic to active or inactive excipients of GnRHa is an exclusion criterion.
Data sourced from ClinicalTrials.gov (NCT02518191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.