Breast CancerNCT06603805
Optimal Surgical Approach for Early-Stage Breast Cancer in Chinese Patients Aged ≤ 40 Years: a Cohort Study
An observational study of Breast Cancer, run by West China Hospital.
Trial summary
The optimal surgical treatment option (BCS+RT versus MAST) for young patients with early-stage breast cancer remains debated. The present study aims to explore trends in surgical management and compare survival outcomes between BCS+RT and MAST in young patients with early-stage breast cancer, ultimately providing… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MAST group and breast-conserving surgery plus adjuvant radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 974 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 1 Jan 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The patient data were extracted from the West China Hospital database at Sichuan University. Records between 1 January 2008 and 31 December 2019 were included.
Who may be able to join
- Patients aged 18-40 years.
- Pathological diagnosis of invasive breast cancer.
- Undergoing Breast-Conserving Surgery (BCS) with Radiotherapy (RT) or Mastectomy (MAST).
- Availability of detailed clinical information, including:
- Tumor (T) stage. Node (N) stage. Clinical stage. Hormone receptor status. Endocrine therapy details. Targeted therapy details.
Who cannot join
- Male patients.
- Patients with distant metastatic disease.
- Patients with bilateral breast cancer.
- Patients not undergoing surgery.
- Follow-up time of less than 1 month.
About this study
The optimal surgical treatment option (BCS+RT versus MAST) for young patients with early-stage breast cancer remains debated. The present study aims to explore trends in surgical management and compare survival outcomes between BCS+RT and MAST in young patients with early-stage breast cancer, ultimately providing optimal treatment strategies for Asian populations.
Read the detailed description
This study is a unique addition to the current research on young women with early-stage breast cancer, aiming to compare the survival outcomes between BCS+RT and MAST, providing valuable insights into their effectiveness for this group of patients. This study enrolled patients at West China Hospital, Sichuan University. Kaplan-Meier analyses with the log-rank test were applied to compare the locoregional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), breast cancer-specific survival (BCSS), and overall survival (OS). Cox multivariate hazard regression was employed to assess hazard ratios (HRs) between the two groups for survival outcomes.
- Conditions
- Breast Cancer
- Being tested
- MAST group, breast-conserving surgery plus adjuvant radiotherapy
- Keywords
- breast cancer, breast-conserving surgery, radiotherapy, 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.
MAST groupProcedure or surgery
breast-conserving surgery plus adjuvant radiotherapyProcedure or surgery
Patients with early-stage (stage I, stage II, T≤2), and having the willingness to receive BCS were treated with BCS. All patients with BCS received post-surgery radiotherapy. Radiotherapy was administrated with a prescribed dose of 40 Gy in 15 fractions with photons and a boost of 10-16 Gy in 5-8 fractions with electrons to the ipsilateral breast. If axillary lymph nodes were involved, a conventional fraction was delivered with a prescribed dose of 50 Gy in 25 fractions to the ipsilateral breast and draining lymph node regions.
| Study group | Role | What they receive |
|---|---|---|
| MAST group | patients 1) aged between 18-40 years; 2) with a primary pathological diagnosis of invasive breast cancer; 3) receiving MAST; 4) having detailed information on T stage, N stage, clinical stage, hormone receptor status, endocrine therapy, and targeted therapy. Receives: Procedure: MAST group | |
| BCS+RT group | Patients 1) aged between 18-40 years; 2) with a primary pathological diagnosis of invasive breast cancer; 3) receiving BCS+ RT; 4) having detailed information on T stage, N stage, clinical stage, hormone receptor status, endocrine therapy, and targeted therapy. Receives: Procedure: breast-conserving surgery plus adjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer-specific survival (BCSS)
Measured: Jan 1, 2008 to 31 Dec, 2019
LRFS (Locoregional Recurrence-Free Survival)
Measured: Jan 1, 2008 to 31 Dec, 2019
DMFS (Distant Metastasis-Free Survival)
Measured: Jan 1, 2008 to 31 Dec, 2019
OS (Overall Survival)
Measured: Jan 1, 2008 to 31 Dec, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2008
- Primary completion31 Dec 2019
- Study completion1 Jan 2024
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 West China 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
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603805
- Sponsor's protocol ID
- 2020427
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Surgical Approach for Early-Stage Breast Cancer in Chinese Patients Aged ≤ 40 Years: a Cohort Study
- ClinicalTrials.gov ID
- NCT06603805
- Acronym / sponsor ID
- 2020427
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast-conserving surgery, radiotherapy, mastectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 19 Sep 2024 (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.
The optimal surgical treatment option (BCS+RT versus MAST) for young patients with early-stage breast cancer remains debated. The present study aims to explore trends in surgical management and compare survival outcomes between BCS+RT and MAST in young patients with early-stage breast cancer, ultimately providing optimal treatment strategies for Asian populations.
Detailed description
This study is a unique addition to the current research on young women with early-stage breast cancer, aiming to compare the survival outcomes between BCS+RT and MAST, providing valuable insights into their effectiveness for this group of patients. This study enrolled patients at West China Hospital, Sichuan University. Kaplan-Meier analyses with the log-rank test were applied to compare the locoregional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), breast cancer-specific survival (BCSS), and overall survival (OS). Cox multivariate hazard regression was employed to assess hazard ratios (HRs) between the two groups for survival outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAST group | – | Procedure: MAST grouppatients 1) aged between 18-40 years; 2) with a primary pathological diagnosis of invasive breast cancer; 3) receiving MAST; 4) having detailed information on T stage, N stage, clinical stage, hormone receptor status, endocrine therapy, and targeted therapy. |
| BCS+RT group | – | Procedure: breast-conserving surgery plus adjuvant radiotherapyPatients 1) aged between 18-40 years; 2) with a primary pathological diagnosis of invasive breast cancer; 3) receiving BCS+ RT; 4) having detailed information on T stage, N stage, clinical stage, hormone receptor status, endocrine therapy, and targeted therapy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patient data were extracted from the West China Hospital database at Sichuan University. Records between 1 January 2008 and 31 December 2019 were included.
Key inclusion criteria (5 listed)
- Patients aged 18-40 years.
- Pathological diagnosis of invasive breast cancer.
- Undergoing Breast-Conserving Surgery (BCS) with Radiotherapy (RT) or Mastectomy (MAST).
- Availability of detailed clinical information, including:
- Tumor (T) stage. Node (N) stage. Clinical stage. Hormone receptor status. Endocrine therapy details. Targeted therapy details.
Key exclusion criteria (5 listed)
- Male patients.
- Patients with distant metastatic disease.
- Patients with bilateral breast cancer.
- Patients not undergoing surgery.
- Follow-up time of less than 1 month.
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 |
|---|---|---|
| MAST group | Procedure or surgery | MAST group |
| breast-conserving surgery plus adjuvant radiotherapyPatients with early-stage (stage I, stage II, T≤2), and having the willingness to receive BCS were treated with BCS. All patients with BCS received post-surgery radiotherapy. Radiotherapy was administrated with a prescribed dose of 40 Gy in 15 fractions with photons and a boost of 10-16 Gy in 5-8 fractions with electrons to the ipsilateral breast. If axillary lymph nodes were involved, a conventional fraction was delivered with a prescribed dose of 50 Gy in 25 fractions to the ipsilateral breast and draining lymph node regions. | Procedure or surgery | BCS+RT group |
Primary outcome
Breast cancer-specific survival (BCSS)
Time frame: Jan 1, 2008 to 31 Dec, 2019
LRFS (Locoregional Recurrence-Free Survival)
Time frame: Jan 1, 2008 to 31 Dec, 2019
DMFS (Distant Metastasis-Free Survival)
Time frame: Jan 1, 2008 to 31 Dec, 2019
OS (Overall Survival)
Time frame: Jan 1, 2008 to 31 Dec, 2019
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 19 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by West China Hospital.
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 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Breast cancer-specific survival (BCSS) (time frame: Jan 1, 2008 to 31 Dec, 2019). The study lists 4 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 19 Sep 2024.