Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients.
Starting soon · Phase 2
Conditions studied: Breast Cancer
In brief
This is a multicenter, prospective, randomized controlled, phase II study. The primary objective is to evaluate the effect of endocrine therapy modification (switching from a 3-month to a 1-month GnRHa) versus continuation of the 3-month GnRHa on E2 control at 3 months in young patients with hormone receptor-positive breast cancer and iOFS.
Key facts
- Study ID
- NCT07610733
- Run by
- Fudan University
- People needed
- 100
- Starts
- 2026-06-01
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Step 1：iOFS detection phase
- Female, aged ≥18 and ≤45 years;
- Histologically confirmed hormone receptor-positive (HR+) (estrogen receptor [ER] and/or progesterone receptor [PR] ≥1%) and human epidermal growth factor receptor 2-negative (HER2-) early invasive breast cancer (stage I-III according to the American Joint Committee on Cancer [AJCC], version 8)；
- Completed curative surgery, with prior (neo)adjuvant chemotherapy and radiotherapy completed if applicable;
- Currently receiving adjuvant therapy with a 3-month GnRH agonist (GnRHa) plus aromatase inhibitor (AI) or tamoxifen (TAM), with or without CDK4/6 inhibitors (excluding abemaciclib due to its potential interference with estradiol monitoring), for ≥1 dose, and presenting with estradiol (E2) ≥30 pg/mL within 28 days prior to enrollment (measured by CLIA).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; adequate bone marrow, hepatic, renal, and cardiac function.
- Voluntarily sign a written informed consent form before the trial screening.
- Step 2：Randomized treatment phase
- iOFS confirmed using the SEMS assay (E2 ≥30 pg/mL);
- Ongoing adjuvant therapy with a 3-month GnRHa plus AI or TAM, with or without CDK4/6 inhibitors.
- No evidence of disease progression.
You may not qualify if…
- Step 1：iOFS detection phase
- Bilateral breast cancer, inflammatory breast cancer, or distant metastasis;
- Use of GnRHa for ovarian function preservation;
- History of ovarian resection or ablation; planned pregnancy or breastfeeding;
- Concomitant use of hormonal agents other than estrogen, progesterone, selective estrogen receptor modulators (SERM), or selective estrogen receptor degraders (SERD);
- Severe uncontrolled comorbidities;
- Other malignancies within the past 5 years (except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma);
- Failure to comply with follow-up or psychiatric disorders.
- Step 2：Randomized treatment phase
- a)Prior conversion from a 3-month GnRHa to a 1-month GnRHa.
Full record on ClinicalTrials.gov
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