Breast CancerNCT06103032
Survival of BCS vs Mx in Asymptomatic Screen-detected NPBC
An observational study of Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
We performed this study on a consecutive cohort of women with asymptomatic screen-detected NPBC. The clinicopathological characteristics, 10-year relapse-free survival (RFS) and overall survival (OS) were compared between BCS and Mx patients among different subgroups. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Conserving Surgery and Mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,020 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Oct 2023
- 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 90 years
- Women only
- Adult, Older adult
Study population: a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer
Who may be able to join
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- Age of at least 18 and at most 90 years. Performance status (Karnofsky-Index) >80%. Chemotherapy is necessary before or after surgery. No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
- Life expectancy of at least 2 years, disregarding the diagnosis of cancer. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
- Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.
Who cannot join
- Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- Local recurrence and/or metastasis of breast cancer. No need of chemotherapy. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
- Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
- Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
- Males.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Long-term Survival of Breast-conserving Surgery Versus Mastectomy in Asymptomatic Screen-detected Unilateral and Bilateral, Unifocal and Multifocal, Young and Elderly Non-palpable Breast Cancer Among Chinese Women
We performed this study on a consecutive cohort of women with asymptomatic screen-detected NPBC. The clinicopathological characteristics, 10-year relapse-free survival (RFS) and overall survival (OS) were compared between BCS and Mx patients among different subgroups.
- Conditions
- Breast Cancer
- Being tested
- Breast Conserving Surgery, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Conserving SurgeryProcedure or surgery
Patients undergoing breast conserving surgery
MastectomyProcedure or surgery
Patients undergoing mastectomy
| Study group | Role | What they receive |
|---|---|---|
| a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer | a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer treated in Dept. Breast Surgery, PUMC Hospital from January 2003 to December 2017 Receives: Procedure: Breast Conserving Surgery; Procedure: Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinicopathological characteristics were compared between BCS and Mx patients
Measured: 15 years
The prognosis was compared between BCS and Mx patients
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion1 Oct 2023
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 Peking Union Medical College 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang SUN, Dr., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103032
- Sponsor's protocol ID
- PUMCH-BSBM
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing according to the privacy of patients.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Survival of Breast-conserving Surgery Versus Mastectomy in Asymptomatic Screen-detected Unilateral and Bilateral, Unifocal and Multifocal, Young and Elderly Non-palpable Breast Cancer Among Chinese Women
- ClinicalTrials.gov ID
- NCT06103032
- Acronym / sponsor ID
- PUMCH-BSBM
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 26 Oct 2023 (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.
We performed this study on a consecutive cohort of women with asymptomatic screen-detected NPBC. The clinicopathological characteristics, 10-year relapse-free survival (RFS) and overall survival (OS) were compared between BCS and Mx patients among different subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer | – | Procedure: Breast Conserving Surgery, Procedure: Mastectomya consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer treated in Dept. Breast Surgery, PUMC Hospital from January 2003 to December 2017 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer
Key inclusion criteria (4 listed)
- Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
- Age of at least 18 and at most 90 years. Performance status (Karnofsky-Index) >80%. Chemotherapy is necessary before or after surgery. No clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
- Life expectancy of at least 2 years, disregarding the diagnosis of cancer. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
- Patients must be available for and compliant to treatment and follow-up. Patients registered on this trial must be treated and followed up at the participating center.
Key exclusion criteria (5 listed)
- Known hypersensitivity reaction to the investigational compounds or incorporated substances.
- Local recurrence and/or metastasis of breast cancer. No need of chemotherapy. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
- Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
- Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
- Males.
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 |
|---|---|---|
| Breast Conserving SurgeryPatients undergoing breast conserving surgery | Procedure or surgery | a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer |
| MastectomyPatients undergoing mastectomy | Procedure or surgery | a consecutive cohort of women with asymptomatic screen-detected non-palpable breast cancer |
Primary outcome
The clinicopathological characteristics were compared between BCS and Mx patients
Time frame: 15 years
The prognosis was compared between BCS and Mx patients
Time frame: 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No. No sharing according to the privacy of patients.
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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.
Qiang SUN, Dr. principal investigator
Peking Union Medical College Hospital
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 Peking Union Medical College 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Oct 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The clinicopathological characteristics were compared between BCS and Mx patients (time frame: 15 years). The study lists 2 primary outcomes in all. 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 Oct 2023.