Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients. (NCT07610733) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients.
100 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants with E2 <30 pg/mL at 3 Months
. 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.