Young Womenwith Breast CancerMYBCNCT05139641
Multidisciplinary Shared Decision Making of Fertility Preservation in Young Women With Breast Cancer
A study testing Counseling to preserve fertility in people with Young Womenwith Breast Cancer, run by MedicalExcellence at 1 site in South Korea.
Trial summary
Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Young Womenwith Breast Cancer
- What is being tested?
- Counseling to preserve fertility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2021to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 19 to 40 years old
- A person diagnosed with breast cancer by biopsy
- Those who don't have evidence of distant metastasis
- Eastern Cooperative Oncology Group(ECOG) performance status: 0-2 score
- Before registering for clinical trials, chemotherapy, radiation therapy, anti-hormone therapy, immunotherapy, and surgery are not performed
- A person who has fully understood and listened to the explanation of this clinical trial and then gave written consent
Who cannot join
- Histologically, a person diagnosed with follicular or sarcoma
- Those with a history of breast cancer (including recurrent breast cancer)
- A person diagnosed with another cancer before breast cancer
- A person diagnosed with metastatic breast cancer
- A person who has a mental illness and has a hard time understanding clinical trials
- Those who plan to conduct follow-up observation elsewhere(to change of hometowm)
Show all 9Show fewer
- Menopausal factors without menstruation after more than a year from the last menstrual date
- A pregnant woman
- Inappropriate for participation in clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Medical Excellence
Seoul
Minjung Kim, mj.kim@mediex.co.kr
Heejeong Kim, MD
About this study
Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial
- Conditions
- Young Womenwith Breast Cancer
- Being tested
- Counseling to preserve fertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling to preserve fertilityBehavioural
Counseling to preserve fertility VS Control group
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Not described Receives: Behavioral: Counseling to preserve fertility |
| counseling theraphy | Experimental | Not described Receives: Behavioral: Counseling to preserve fertility |
| Retrospective data | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
selection ratio of fertility preservation procedure
Measured: selection ratio of fertility preservation procedure from Baseline to six years
Secondary outcomes (1)
The success rate of pregnancy
Measured: The success rate of pregnancy from Baseline to six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Young Womenwith Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedicalExcellence
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139641
- Sponsor's protocol ID
- MYBC
- Acronym
- MYBC
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baek SY, Kim HK, Park S, Yu JH, Lee MH, Youn HJ, Kim HA, Han JH, Choi JE, Lee JR, Lee KH, Chung S, Chae HD, Kim S, Yoo S, Hahm SK, Kim HJ. Multidisciplinary Shared Decision Making for Fertility Preservation in Young Women With Breast Cancer. J Breast Cancer. 2023 Dec;26(6):582-592. doi: 10.4048/jbc.2023.26.e44. Epub 2023 Oct 11.
PubMed 37985382
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Shared Decision Making of Fertility Preservation in Young Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT05139641
- Acronym / sponsor ID
- MYBC / MYBC
- Conditions
- Young Womenwith Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- MedicalExcellenceUniversity, hospital or other
- Collaborators
- Asan Medical Center
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Dec 2021 (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.
Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Behavioral: Counseling to preserve fertility |
| counseling theraphy | Experimental | Behavioral: Counseling to preserve fertility |
| Retrospective data | No intervention | – |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 19 to 40 years old
- A person diagnosed with breast cancer by biopsy
- Those who don't have evidence of distant metastasis
- Eastern Cooperative Oncology Group(ECOG) performance status: 0-2 score
- Before registering for clinical trials, chemotherapy, radiation therapy, anti-hormone therapy, immunotherapy, and surgery are not performed
Key exclusion criteria (9 listed)
- Histologically, a person diagnosed with follicular or sarcoma
- Those with a history of breast cancer (including recurrent breast cancer)
- A person diagnosed with another cancer before breast cancer
- A person diagnosed with metastatic breast cancer
- A person who has a mental illness and has a hard time understanding clinical trials
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 |
|---|---|---|
| Counseling to preserve fertilityCounseling to preserve fertility VS Control group | Behavioural | control group, counseling theraphy |
Primary outcome
selection ratio of fertility preservation procedure
Time frame: selection ratio of fertility preservation procedure from Baseline to six years
1 secondary outcome
The success rate of pregnancy
Time frame: The success rate of pregnancy from Baseline to six years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Derived from this study: PubMed 37985382Baek SY, Kim HK, Park S, Yu JH, Lee MH, Youn HJ, Kim HA, Han JH, Choi JE, Lee JR, Lee KH, Chung S, Chae HD, Kim S, Yoo S, Hahm SK, Kim HJ. Multidisciplinary Shared Decision Making for Fertility Preservation in Young Women With Breast Cancer. J Breast Cancer. 2023 Dec;26(6):582-592. doi: 10.4048/jbc.2023.26.e44. Epub 2023 Oct 11.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling to preserve fertility in people with Young Womenwith Breast Cancer, run by MedicalExcellence 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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 1 Dec 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minjung Kim (82-2-3482-7809, mj.kim@mediex.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
selection ratio of fertility preservation procedure (time frame: selection ratio of fertility preservation procedure from Baseline to six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05139641, which also lists 1 linked publication.
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 1 Dec 2021.