Breast CancerNCT05474391
MammaPrint Value for Pre-menopausal Breast Cancer Patients
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Nearly 200 cases are to be enrolled. The information of patient age, histologic grade, tumor size, ER and PR status, Ki-67 index, surgery mode should be provided. The adjuvant therapy regime (chemotherapy: none, TC*4, TC*6 or EC-T; endocrine therapy: TAM, OFS+TAM, OFS+AI) will be compared before and after MammaPrint… Read more about this study
- Who is it for?
- Ages Up to 50 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 15 Jul 2024
- Phase
- Observational
- 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 Up to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with breast cancer (according to ICD-10)
Who may be able to join
- pre-menopausal breast cancer patients aged less than 50 years old.
- Pathology confirmed invasive dutal carcinoma or invasive lobular carcinoma.
- receiving breast conserving surgery or mastectomy with/without reconstruction; sentinel lymph node biopsy or axillary lymph node dissection.
- TNM staging: T1b-T2N0-1M0.
- molecular subtype: ER positive/HER2 negative.
- MammaPrint testing before initiation of adjuvant therapy.
Who cannot join
- Incomplete medical history.
- Pregnancy or lactation.
- Contradiction of chemotherapy or ovarian function suppression.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: The Value of MammaPrint in Adjuvant Therapy Decision Among Pre-menopausal Breast Cancer Patients: a Survey Based on Clinical Staff
Nearly 200 cases are to be enrolled. The information of patient age, histologic grade, tumor size, ER and PR status, Ki-67 index, surgery mode should be provided. The adjuvant therapy regime (chemotherapy: none, TC*4, TC*6 or EC-T; endocrine therapy: TAM, OFS+TAM, OFS+AI) will be compared before and after MammaPrint testing. About 20 clinical staffs are enrolled to participate in this survey for the clinical decision making. Each case could be chosen five times at random.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MammaPrint group | Pre-menopausal breast cancer patients received MammaPrint test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment decision survey
Treatment decision change after MammaPrint testing
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start15 Jul 2022
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
- Investigators
- Biyun Wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474391
- Sponsor's protocol ID
- YOUNGBC-16
- Status last verified
- Feb 2024
- First submitted
- 22 Jul 2022
- Last updated
- 26 Feb 2024
- Results posted
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of MammaPrint in Adjuvant Therapy Decision Among Pre-menopausal Breast Cancer Patients: a Survey Based on Clinical Staff
- ClinicalTrials.gov ID
- NCT05474391
- Acronym / sponsor ID
- YOUNGBC-16
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 26 Jul 2022 (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.
Nearly 200 cases are to be enrolled. The information of patient age, histologic grade, tumor size, ER and PR status, Ki-67 index, surgery mode should be provided. The adjuvant therapy regime (chemotherapy: none, TC*4, TC*6 or EC-T; endocrine therapy: TAM, OFS+TAM, OFS+AI) will be compared before and after MammaPrint testing. About 20 clinical staffs are enrolled to participate in this survey for the clinical decision making. Each case could be chosen five times at random.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MammaPrint group | – | –Pre-menopausal breast cancer patients received MammaPrint test. |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with breast cancer (according to ICD-10)
Key inclusion criteria (6 listed)
- pre-menopausal breast cancer patients aged less than 50 years old.
- Pathology confirmed invasive dutal carcinoma or invasive lobular carcinoma.
- receiving breast conserving surgery or mastectomy with/without reconstruction; sentinel lymph node biopsy or axillary lymph node dissection.
- TNM staging: T1b-T2N0-1M0.
- molecular subtype: ER positive/HER2 negative.
Key exclusion criteria (3 listed)
- Incomplete medical history.
- Pregnancy or lactation.
- Contradiction of chemotherapy or ovarian function suppression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment decision survey
Time frame: 6 weeks
Treatment decision change after MammaPrint testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- 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.
Biyun Wang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
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 3 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 26 Feb 2024. 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 China. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment decision survey (time frame: 6 weeks). 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 26 Feb 2024.