NCT07610733Not yet recruitingPhase 2
Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients.
A Multicenter, Prospective, Randomized Controlled Study-Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients (IFOCOS)
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 14 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Fudan University
- Diseases
- Ovarian cancer
- NCT number
- NCT07610733
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 1 Jun 2026 to the primary completion date, 1 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of hormonal agents other than estrogen, progesterone, selective estrogen receptor modulators (SERM), or selective estrogen receptor degraders (SERD);
- 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.
Other illness
- Bilateral breast cancer, inflammatory breast cancer, or distant metastasis;
- History of ovarian resection or ablation; planned pregnancy or breastfeeding;
- Other malignancies within the past 5 years (except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma);
Other
- Step 1：iOFS detection phase
- Use of GnRHa for ovarian function preservation;
- Severe uncontrolled comorbidities;
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.