Breast CancerNCT06299930
Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy
An observational study of Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neoadjuvant chemotherapy and Adjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 10,328 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Apr 2022to 12 Sep 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 100 years
- Women only
- Adult, Older adult
Study population: Female patients who underwent breast-conserving surgery for breast cancer between January 1, 2004 and December 31, 2018 at the three leading hospitals in South Korea
Who may be able to join
- Patients who underwent breast-conserving surgery for invasive breast cancer between 2004 and 2018
Who cannot join
- Total mastectomy
- No pre- or postoperative chemotherapy
- No radiation therapy
- Bilateral breast cancer
- Male breast cancer patients
- Secondary breast cancer
- Metachronous or synchronous cancers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy Based on Tumor Subtypes in Patients With Early-stage Breast Cancer: A Multi-institutional Retrospective Cohort Study
Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018.
- Conditions
- Breast Cancer
- Being tested
- Neoadjuvant chemotherapy, Adjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapyProcedure or surgery
Also called NACT
Patients received neoadjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) , followed by surgery and radiotherapy
Adjuvant chemotherapyProcedure or surgery
Also called ACT
Patients received adjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) after surgery, followed by radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy (NACT) group | Patients who administered chemotherapy before surgery Receives: Procedure: Neoadjuvant chemotherapy | |
| Adjuvant chemotherapy (ACT) group | Patients who administered chemotherapy after surgery Receives: Procedure: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional recurrence-free survival (LRR)
Time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of locoregional recurrence
Measured: Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of LRR, assessed up to 120 months
Secondary outcomes (1)
Distant metastasis-free survival
Time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of distant metastasis
Measured: Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of distant metastasis, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start22 Apr 2022
- Primary completion16 Aug 2023
- Study completion12 Sep 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 Seoul National University 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
- Retrospective
- Enrolment
- 10,328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wonshik Han, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299930
- Sponsor's protocol ID
- LRR after NACT vs ACT
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy Based on Tumor Subtypes in Patients With Early-stage Breast Cancer: A Multi-institutional Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06299930
- Acronym / sponsor ID
- LRR after NACT vs ACT
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,328 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 8 Mar 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.
Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy (NACT) group | – | Procedure: Neoadjuvant chemotherapyPatients who administered chemotherapy before surgery |
| Adjuvant chemotherapy (ACT) group | – | Procedure: Adjuvant chemotherapyPatients who administered chemotherapy after surgery |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female patients who underwent breast-conserving surgery for breast cancer between January 1, 2004 and December 31, 2018 at the three leading hospitals in South Korea
Key inclusion criteria (1 listed)
- Patients who underwent breast-conserving surgery for invasive breast cancer between 2004 and 2018
Key exclusion criteria (7 listed)
- Total mastectomy
- No pre- or postoperative chemotherapy
- No radiation therapy
- Bilateral breast cancer
- Male breast cancer patients
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 |
|---|---|---|
| Neoadjuvant chemotherapyAlso: NACTPatients received neoadjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) , followed by surgery and radiotherapy | Procedure or surgery | Neoadjuvant chemotherapy (NACT) group |
| Adjuvant chemotherapyAlso: ACTPatients received adjuvant chemotherapy (either taxane-or anthracycline-based, or any cytotoxic chemotherapy) after surgery, followed by radiotherapy | Procedure or surgery | Adjuvant chemotherapy (ACT) group |
Primary outcome
Locoregional recurrence-free survival (LRR)
Time frame: Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of LRR, assessed up to 120 months
Time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of locoregional recurrence
1 secondary outcome
Distant metastasis-free survival
Time frame: Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of distant metastasis, assessed up to 120 months
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 8 Mar 2024.
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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.
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 Seoul National University Hospital at 1 site in South Korea.
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 1 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: finished, as of the sponsor's last update on 8 Mar 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 South Korea. 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?
Locoregional recurrence-free survival (LRR) (time frame: Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of LRR, assessed up to 120 months). 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 8 Mar 2024.