Investigating the effect of adding ovarian function suppression to tamoxifen in premenopausal women with breast cancer
Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment
This study is testing if adding ovarian function suppression to tamoxifen can help premenopausal women with breast cancer see better results in their treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03664895 on ClinicalTrials.gov |
What this trial studies
The DELFINO trial aims to evaluate the impact of adding ovarian function suppression (OFS) to tamoxifen (TMX) treatment in premenopausal women with invasive breast cancer. This phase III, randomized controlled trial will enroll 224 participants and assess mammography (MMG) density as a surrogate marker for hormone therapy effectiveness. Patients will be monitored for changes in MMG density after one year of TMX treatment, with those showing insufficient density reduction randomized to receive either TMX alone or TMX with OFS. The primary endpoint is the mammography density reduction after five years, alongside secondary endpoints of disease-free survival and overall survival.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women diagnosed with estrogen receptor-positive breast cancer who are planning to undergo tamoxifen treatment.
Not a fit: Patients who have undergone prior endocrine therapy or those who are postmenopausal will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for premenopausal women with breast cancer by improving the effectiveness of hormone therapy.
How similar studies have performed: Previous studies have indicated that mammography density reduction is achievable with endocrine therapy, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premenopausal women, ER+ breast cancer, stage I\~III, underwent standard treatment including surgery, Planned TMX * available MMG density check via Volpara Exclusion Criteria: * Bilateral breast cancer * Prior endocrine therapy * Postmenopausal status * unavailable MMG density check via volpara before and after TMX
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Eun-Shin Lee
- Email: silvershoe99@gmail.com
- Phone: 82-2-2072-0173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.