Breast CancerNCT05126667
Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy
An observational study of Breast Cancer, run by European Institute of Oncology.
Trial summary
This is a retrospective propensity score-matched analysis of a large institutional cohort of patients in order to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery or mastectomy for breast cancer. Read more about this study
- Who is it for?
- Any age, 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
- 9,710 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Nov 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospectively analysis of patients who received treatment for invasive breast cancer at the European Institute of Oncology between January 1, 2000, and December 31, 2008. The original cohort comprised 9710 eligible patients with breast cancer, of whom 2289 (23.6%) underwent breast conserving surgery + whole breast irradiation and 7421 (76.4%) underwent mastectomy alone. After propensity score matching, 1970 of the 2289 patients who underwent mastectomy (86.1%) were successfully matched to 1970 patients who underwent breast conserving surgery.
Who may be able to join
- First primary breast cancer
- pT1-2
- pN0-3a
- Surgery performed at European Institute of Oncology between 2000 and 2008
Who cannot join
- pT>=3
- Neoadjuvant treatment
- Presence of metastatic breast disease at the time of admission or within 3 months
About this study
Official title: A Propensity Score-Matched Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy in Breast Cancer
This is a retrospective propensity score-matched analysis of a large institutional cohort of patients in order to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery or mastectomy for breast cancer.
Read the detailed description
The aim of the study is to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery + whole breast irradiation or mastectomy for breast cancer.
Recent observations regarding long-term outcomes among patients with early-stage breast cancer who underwent breast-conserving surgery plus whole-breast irradiation or mastectomy are from a small number of registry-based studies.
Therefore, these findings may overestimate differences in survival between the two groups, compared with randomized controlled trials conducted in the 1980s.
This study performed a propensity score-matched analysis in a cohort of 9710 patients aged <70 years who underwent breast conserving surgery + whole breast irradiation or mastectomy without external radiotherapy for a first primary breast cancer (pT1-2, N0-3a) at the European Institute of Oncology between 2000 and 2008.
Patients were matched by propensity score.
- 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
Breast conserving surgery plus whole breast irradiation
MastectomyProcedure or surgery
Breast mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Breast-conserving surgery | Patients who underwent breast-conserving surgery plus whole-breast irradiation Receives: Procedure: Breast-conserving surgery | |
| Mastectomy | Patients who underwent mastectomy Receives: Procedure: Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of ipsilateral breast tumor recurrence
Incidence of ipsilateral breast tumor recurrence in breast conserving surgery group compared to mastectomy group
Measured: 10 years
Cumulative incidence of axillary lymph node recurrence
cumulative incidence of axillary lymph node recurrence in breast conserving surgery group compared to mastectomy group
Measured: 10 years
Cumulative incidence of contralateral breast cancer
Cumulative incidence of contralateral breast cancer in breast conserving surgery group compared to mastectomy group
Measured: 10 years
Rate of distant metastasis
Incidence of distant metastasis in breast conserving surgery group compared to mastectomy group
Measured: 10 years
Cumulative incidence of breast cancer specific survival
Cumulative incidence of breast cancer specific survival in breast conserving surgery group compared to mastectomy group
Measured: 10 years
Rate of overall survival
Incidence of survival in breast conserving surgery group compared to mastectomy group
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study startJan 2000
- Primary completionNov 2021
- Study completionNov 2021
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 European Institute of OncologyThe 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
- 9,710 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Magnoni, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126667
- Sponsor's protocol ID
- UID 2762
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Propensity Score-Matched Analysis of Breast-Conserving Surgery Plus Whole-Breast Irradiation Versus Mastectomy in Breast Cancer
- ClinicalTrials.gov ID
- NCT05126667
- Acronym / sponsor ID
- UID 2762
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,710 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Jan 2000 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 19 Nov 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 retrospective propensity score-matched analysis of a large institutional cohort of patients in order to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery or mastectomy for breast cancer.
Detailed description
The aim of the study is to compare long-term outcomes and clinicopathologic characteristics between patients treated with breast conserving surgery + whole breast irradiation or mastectomy for breast cancer.
Recent observations regarding long-term outcomes among patients with early-stage breast cancer who underwent breast-conserving surgery plus whole-breast irradiation or mastectomy are from a small number of registry-based studies.
Therefore, these findings may overestimate differences in survival between the two groups, compared with randomized controlled trials conducted in the 1980s.
This study performed a propensity score-matched analysis in a cohort of 9710 patients aged <70 years who underwent breast conserving surgery + whole breast irradiation or mastectomy without external radiotherapy for a first primary breast cancer (pT1-2, N0-3a) at the European Institute of Oncology between 2000 and 2008.
Patients were matched by propensity score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast-conserving surgery | – | Procedure: Breast-conserving surgeryPatients who underwent breast-conserving surgery plus whole-breast irradiation |
| Mastectomy | – | Procedure: MastectomyPatients who underwent mastectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospectively analysis of patients who received treatment for invasive breast cancer at the European Institute of Oncology between January 1, 2000, and December 31, 2008. The original cohort comprised 9710 eligible patients with breast cancer, of whom 2289 (23.6%) underwent breast conserving surgery + whole breast irradiation and 7421 (76.4%) underwent mastectomy alone. After propensity score matching, 1970 of the 2289 patients who underwent mastectomy (86.1%) were successfully matched to 1970 patients who underwent breast conserving surgery.
Key inclusion criteria (4 listed)
- First primary breast cancer
- pT1-2
- pN0-3a
- Surgery performed at European Institute of Oncology between 2000 and 2008
Key exclusion criteria (3 listed)
- pT>=3
- Neoadjuvant treatment
- Presence of metastatic breast disease at the time of admission or within 3 months
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 surgeryBreast conserving surgery plus whole breast irradiation | Procedure or surgery | Breast-conserving surgery |
| MastectomyBreast mastectomy | Procedure or surgery | Mastectomy |
Primary outcome
Cumulative incidence of ipsilateral breast tumor recurrence
Time frame: 10 years
Incidence of ipsilateral breast tumor recurrence in breast conserving surgery group compared to mastectomy group
Cumulative incidence of axillary lymph node recurrence
Time frame: 10 years
cumulative incidence of axillary lymph node recurrence in breast conserving surgery group compared to mastectomy group
Cumulative incidence of contralateral breast cancer
Time frame: 10 years
Cumulative incidence of contralateral breast cancer in breast conserving surgery group compared to mastectomy group
Rate of distant metastasis
Time frame: 10 years
Incidence of distant metastasis in breast conserving surgery group compared to mastectomy group
Cumulative incidence of breast cancer specific survival
Time frame: 10 years
Cumulative incidence of breast cancer specific survival in breast conserving surgery group compared to mastectomy group
Rate of overall survival
Time frame: 10 years
Incidence of survival in breast conserving surgery group compared to mastectomy group
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 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Francesca Magnoni, MD principal investigator
European Institute of Oncology
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by European Institute of Oncology.
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 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: finished, as of the sponsor's last update on 19 Nov 2021. 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?
Cumulative incidence of ipsilateral breast tumor recurrence (time frame: 10 years). The study lists 6 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 Nov 2021.