Breast Cancer InvasivePhase 3NCT03664895
Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)
A Phase 3 study testing Leuplin or zoladex in people with Breast Cancer Invasive, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women Premise - MMG density as a surrogate marker of hormone therapy Assumption - "Add on OFS to TMX" would have further decrease of density 3-arm(Observation arm + Randomised 2-arm)… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Breast Cancer Invasive
- What is being tested?
- Leuplin or zoladex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Sep 2018to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women, ER+ breast cancer, stage I~III, underwent standard treatment including surgery, Planned TMX
- available MMG density check via Volpara
Who cannot join
- Bilateral breast cancer
- Prior endocrine therapy
- Postmenopausal status
- unavailable MMG density check via volpara before and after TMX
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Wonshik Han, MD PhD, 82-2-2072-1958, hanw@snu.ac.kr
Eun-Shin Lee, MD, silvershoe99@gmail.com
About this study
Official title: Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment
DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women
- Premise - MMG density as a surrogate marker of hormone therapy
- Assumption - "Add on OFS to TMX" would have further decrease of density
- 3-arm(Observation arm + Randomised 2-arm), phase III, RCT with 1:1 allocation
Read the detailed description
Enroll : Sep03,2018~(Planned N= 224)
- Inclusion criteria
- Premenopausal
- ER+
- Planned tamoxifen(TMX)
- No planned ovary function suppression(OFS)
- Regardless of ChemoTx
- Mammography(MMG) density check via Volpara*(=Baseline MMG density, BaMD) (*Volpara= software to check MMG density)
- Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH <30)
- MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr
- MDR ≥5% -> Keep go on TMX MDR <5% -> 1:1 randomization -> Keep go on TMX vs OFS add on to TMX
- Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS
- Calculation of patients' number In previous study(<Kim et al. Breast Can Res 2012>) MDR (Mammography Density Reduction) was found in about 50% of all patients who received endocrine therapy.
Expected
- MDR in "TMX only" cohort -> 6 ± 7%
- MDR in "OFS add on to TMX" -> 10 ± 7%
- after 1yr, Significance level 5%, average MDR 4% difference, 80% power, 10% dropout rate => 1:1 randomization Number = 112(56:56) Total number = 224
- Conditions
- Breast Cancer Invasive
- Being tested
- Leuplin or zoladex
- Keywords
- premenopausal women, MMG density, Ovary function suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuplin or zoladexDrug
OFS(Leuplin or zoladex) add on to TMX
| Study group | Role | What they receive |
|---|---|---|
| observation arm(TMX, MDR≥5%) | No intervention | keep go on TMX |
| control arm(TMX, MDR<5%) | No intervention | keep go on TMX |
| OFS add arm(TMX + OFS, MDR<5%) | Active comparator | OFS add on to TMX Receives: Drug: Leuplin or zoladex |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMG density Reduction
Measured: 5 years
Secondary outcomes (1)
Disease free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start3 Sep 2018
- Primary completion2 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wonshik Han, Study chair, Seoul National University College of Medicine/Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664895
- Sponsor's protocol ID
- DELFINO trial
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2018
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment
- ClinicalTrials.gov ID
- NCT03664895
- Acronym / sponsor ID
- DELFINO trial
- Conditions
- Breast Cancer Invasive
- Keywords
- premenopausal women, MMG density, Ovary function suppression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 2 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women
- Premise - MMG density as a surrogate marker of hormone therapy
- Assumption - "Add on OFS to TMX" would have further decrease of density
- 3-arm(Observation arm + Randomised 2-arm), phase III, RCT with 1:1 allocation
Detailed description
Enroll : Sep03,2018~(Planned N= 224)
- Inclusion criteria
- Premenopausal
- ER+
- Planned tamoxifen(TMX)
- No planned ovary function suppression(OFS)
- Regardless of ChemoTx
- Mammography(MMG) density check via Volpara*(=Baseline MMG density, BaMD) (*Volpara= software to check MMG density)
- Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH <30)
- MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr
- MDR ≥5% -> Keep go on TMX MDR <5% -> 1:1 randomization -> Keep go on TMX vs OFS add on to TMX
- Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS
- Calculation of patients' number In previous study(<Kim et al. Breast Can Res 2012>) MDR (Mammography Density Reduction) was found in about 50% of all patients who received endocrine therapy.
Expected
- MDR in "TMX only" cohort -> 6 ± 7%
- MDR in "OFS add on to TMX" -> 10 ± 7%
- after 1yr, Significance level 5%, average MDR 4% difference, 80% power, 10% dropout rate => 1:1 randomization Number = 112(56:56) Total number = 224
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| observation arm(TMX, MDR≥5%) | No intervention | –keep go on TMX |
| control arm(TMX, MDR<5%) | No intervention | –keep go on TMX |
| OFS add arm(TMX + OFS, MDR<5%) | Active comparator | Drug: Leuplin or zoladexOFS add on to TMX |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Premenopausal women, ER+ breast cancer, stage I~III, underwent standard treatment including surgery, Planned TMX
- available MMG density check via Volpara
Key exclusion criteria (4 listed)
- Bilateral breast cancer
- Prior endocrine therapy
- Postmenopausal status
- unavailable MMG density check via volpara before and after TMX
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuplin or zoladexOFS(Leuplin or zoladex) add on to TMX | Drug | OFS add arm(TMX + OFS, MDR<5%) |
Primary outcome
MMG density Reduction
Time frame: 5 years
1 secondary outcome
Disease free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wonshik Han study chair
Seoul National University College of Medicine/Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leuplin or zoladex in people with Breast Cancer Invasive, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun-Shin Lee (82-2-2072-0173, silvershoe99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMG density Reduction (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.