Breast CancerNCT04970264
A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer
An observational study of Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Mar 2025
- How long will I take part?
- 5 Years
- 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 18 to 35 years
- Women only
- Adult
Study population: We expect to enroll 2000 young breast cancer patients (18-35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Subgroups were stratified according to different stages, treatment methods and pathological types. The gene mutation characteristics, treatment sensitive genes and prognosis gene spectrum of different groups and subgroups were studied.
Who may be able to join
- Histologically confirmed as breast cancer.
- The age of diagnosis was 18-35 years old.
- ECOG score was 0-2, and the expected survival time was more than 3 months.
- No serious complications; no liver, kidney, hematopoiesis dysfunction.
- Informed consent, and patients willing to long-term follow-up. -
Who cannot join
- 4 weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study.
- Having a clear history of neurological or mental disorders (including epilepsy or dementia).
- Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders.
- Pregnant or lactating female patients.
- HIV infected patients.
- Patients with other tumors.
- After comprehensive evaluation, the researchers believe that patients are not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TianJin Medical University Cancer Institute and Hospital
Tianjin, 300060
Hong MD Liu, professor, 18622221169, lh713@163.com
About this study
Official title: A Observational RWS of YWBC on the Prognosis and Treatment
This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients.
We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.
Read the detailed description
The study can only be formally carried out with the written approval of the ethics committee. We regularly submit annual research reports to the ethics committee. We will inform the ethics committee in writing when the study is discontinued and / or completed.
All patients were required to sign informed consent before entering the group. All updated versions of informed consent and written information will be provided to the subjects during the participant's participation.
In the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. Employ statistical experts to calculate the sample size and data statistics, and participate in the design process. Data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. They will ensure the authenticity, reliability and security of data throughout the process.
- Conditions
- Breast Cancer
- Keywords
- young women with breast cancer, gene mutation characteristics, prognosis
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from the first medication at the beginning of treatment to the first disease progression or death from any cause
Measured: 5 years
Secondary outcomes (2)
OS
time from randomization to death from any cause
Measured: 5 years
ORR
After treatment, the percentage of patients whose tumor volume reduced to a predetermined value and could maintain the minimum time limit was evaluated, including complete remission (CR) + partial remission (PR)
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 posted21 Jul 2021
- Study start1 Apr 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2025 (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 Tianjin Medical University Cancer Institute and 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970264
- Sponsor's protocol ID
- YWBC-001
- Status last verified
- Apr 2021
- First submitted
- 26 Feb 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Observational RWS of YWBC on the Prognosis and Treatment
- ClinicalTrials.gov ID
- NCT04970264
- Acronym / sponsor ID
- YWBC-001
- Conditions
- Breast Cancer
- Keywords
- young women with breast cancer, gene mutation characteristics, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Jul 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.
This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients.
We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.
Detailed description
The study can only be formally carried out with the written approval of the ethics committee. We regularly submit annual research reports to the ethics committee. We will inform the ethics committee in writing when the study is discontinued and / or completed.
All patients were required to sign informed consent before entering the group. All updated versions of informed consent and written information will be provided to the subjects during the participant's participation.
In the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. Employ statistical experts to calculate the sample size and data statistics, and participate in the design process. Data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. They will ensure the authenticity, reliability and security of data throughout the process.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- We expect to enroll 2000 young breast cancer patients (18-35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Subgroups were stratified according to different stages, treatment methods and pathological types. The gene mutation characteristics, treatment sensitive genes and prognosis gene spectrum of different groups and subgroups were studied.
Key inclusion criteria (5 listed)
- Histologically confirmed as breast cancer.
- The age of diagnosis was 18-35 years old.
- ECOG score was 0-2, and the expected survival time was more than 3 months.
- No serious complications; no liver, kidney, hematopoiesis dysfunction.
- Informed consent, and patients willing to long-term follow-up. -
Key exclusion criteria (7 listed)
- 4 weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study.
- Having a clear history of neurological or mental disorders (including epilepsy or dementia).
- Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders.
- Pregnant or lactating female patients.
- HIV infected patients.
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
PFS
Time frame: 5 years
The time from the first medication at the beginning of treatment to the first disease progression or death from any cause
2 secondary outcomes
OS
Time frame: 5 years
ORR
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 21 Jul 2021.
Related trials for Breast Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
Not yet recruitingPhase 2
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
Breast Cancer, Advanced Breast Cancer
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
RecruitingPhase 2
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
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.
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 Tianjin Medical University Cancer Institute and Hospital 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 5 inclusion and 7 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 21 Jul 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 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?
Contact Hong MD Liu, professor (18622221169, lh713@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (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 21 Jul 2021.