Breast CancerNCT06149377
Impact of a Predictive Model on Sentinel Lymph Node Biopsy in Initially Lymph Node-positive, HER2-positive Breast Cancer
An observational study of Breast Cancer and Sentinel Lymph Node, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
The aim of the study was to develop and validate a nomogram to assess axillary pathological complete response (pCR) in patients with initially lymph node-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer and test its performance in guiding patient selection for sentinel lymph node biopsy… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node
- What is being tested?
- Test cohort
- Type of treatment
- Surgery or procedure
- How many people
- 716 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2012to 31 May 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 Any age
- Women only
- Child, Adult, Older adult
Study population: The investigators retrospectively reviewed the medical records of 597 patients at four institutions from April 1, 2012, to May 30, 2022. Patients from institution 1 (n = 386) served as the training cohort, whereas those from the other institutions (n = 211) served as an external validation cohort. A test cohort (n=119) who accepted SLNB followed ALND was collected to assess the predictive power of the model ，from June 1,2022 to We retrospectively reviewed the medical records of patients from Fujian Medical University Union Hospital (n = 386) as the training cohort and those from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, and No. 900 Hospital of The Joint Logistic Support Force (n = 211) as an external validation cohort from April 1, 2012, to March 31, 2022. Additionally, 119 patients were enrolled as the test cohort to assess the predictive power of the model from May 1, 2022, to May 31, 2023.
Who may be able to join
- histologically proven primary breast cancer without distant metastatic lesions,
- HER2-positive status (defined as immunohistochemistry (IHC) of 3+ overexpression or 2+ expression, and a ratio of ≥ 2.0 by fluorescence in situ hybridization),
- initial axillary lymph node-positive status confirmed using core- or fine-needle biopsy before NST,
- a full course of standard neoadjuvant therapy before surgery
- complete clinicopathological characteristics and treatment information.
Who cannot join
- do not plan or are unable to operate;
- with distant metastasis
- do not accept full cycles or standard neoadjuvant systemic therapy
- loss of clinicopathological characteristics and treatment information.
- with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non-tumor related diseases who could not tolerate comprehensive treatment such as surgery and chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of a Predictive Model on Sentinel Lymph Node Biopsy in Initially Lymph Node-positive, HER2-positive Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter Retrospective Study
The aim of the study was to develop and validate a nomogram to assess axillary pathological complete response (pCR) in patients with initially lymph node-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer and test its performance in guiding patient selection for sentinel lymph node biopsy (SLNB) following neoadjuvant systemic therapy (NST).
Read the detailed description
We retrospectively reviewed the medical records of patients from Fujian Medical University Union Hospital (n = 386) as the training cohort and those from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, and No. 900 Hospital of The Joint Logistic Support Force (n = 211) as an external validation cohort from April 1, 2012, to March 31, 2022. Additionally, 119 patients were enrolled as the test cohort to assess the predictive power of the model from May 1, 2022, to May 31, 2023.The inclusion criteria included: 1) histologically proven primary breast cancer without distant metastatic lesions, 2) HER2-positive status (defined as immunohistochemistry (IHC) of 3+ overexpression or 2+ expression, and a ratio of ≥ 2.0 by fluorescence in situ hybridization), 3) initial axillary lymph node-positive status confirmed using core- or fine-needle biopsy before NST, 4) a full course of standard neoadjuvant therapy before surgery, and 5) complete clinicopathological characteristics and treatment information. The study was approved by ethics committee of Fujian Medical University Union Hospital. All patients in the training and validation cohorts underwent mastectomy, breast-conserving surgery, radiation, and ALND surgery after completing NST. All patients in the additional independent cohort underwent SLNB followed by ALND, which detected at least 2 SLNs using methylene blue dye alone. SLNs were defined as blue-stained lymph nodes guided directly by blue-stained lymphatic vessels. Methylene blue dye was injected alone at peritumoral or subareolar sites 5-15 min before SLNB. After constructing the nomogram for predicting axillary pCR with the independent predictive factors, the investigators quantified the predictive performance of the model using the AUC of the receiver operating characteristic curve. Calibration plots with bootstrapping and the Hosmer-Lemeshow test were used to illustrate the calibration power of the model, with p > 0.05 indicating a good fit.20 The clinical utility of the model in guiding surgical options was evaluated using decision curve analysis by plotting net benefits.21 Internal validation was estimated using the bootstrap method. The investigators validated the nomogram using an external validation cohort from the other institutions. Following the Youden index, the investigators selected an optimal cutoff probability of predicting axillary pCR as a stratification criterion for identifying patients who underwent SLNB surgery after NST. The investigators additionally examined 119 patients who underwent SLNB with ≥ 2 SLNs removed, followed by ALND, as an independent cohort to evaluate the effect of the nomogram on identifying patients accurately. FNRs of SLNB were compared using two different strategies: performing SLNB in all patients without any selection criteria and performing SLNB in patients selected by the nomogram with the cutoff probability of axillary pCR. These results were compared with those of the two previous tests.
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Being tested
- Test cohort
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test cohortProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Patients (n=386) who accepted neoadjuvant systemic therapy followed surgery were from fujian medical university union hospital from April 1, 2012, to May 30, 2022. | |
| External validation cohort | Patients (n=211) who accepted neoadjuvant systemic therapy followed surgery were from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University and No. 900 Hospital of The Joint Logistic Support Force from April 1, 2012, to May 30, 2022. | |
| Test cohort | Patients (n=119) who accepted sentinel lymph node biopsy followed axillary lymph node dissection after neoadjuvant systemic therapy was retrospectively collected from June 1,2022 to May 31, 2023. Receives: Procedure: Test cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary pCR
the percent of patients who achieved axillary pathological complete response after NST.
Measured: 10 years
Secondary outcomes (1)
the False Negative Rate of SLNB
the percent of patients with residual lymph node disease were not identified.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Apr 2012
- Primary completion31 May 2023
- Study completion31 May 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.
- 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
- 716 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuan Wang, Fujian Medical University Union Hospital
- Investigators
- China Fujian, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149377
- Sponsor's protocol ID
- NSFFP-2023Y0020
- Status last verified
- Dec 2023
- First submitted
- 4 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Predictive Model on Sentinel Lymph Node Biopsy in Initially Lymph Node-positive, HER2-positive Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06149377
- Acronym / sponsor ID
- NSFFP-2023Y0020
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 716 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 29 Nov 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.
The aim of the study was to develop and validate a nomogram to assess axillary pathological complete response (pCR) in patients with initially lymph node-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer and test its performance in guiding patient selection for sentinel lymph node biopsy (SLNB) following neoadjuvant systemic therapy (NST).
Detailed description
We retrospectively reviewed the medical records of patients from Fujian Medical University Union Hospital (n = 386) as the training cohort and those from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, and No. 900 Hospital of The Joint Logistic Support Force (n = 211) as an external validation cohort from April 1, 2012, to March 31, 2022. Additionally, 119 patients were enrolled as the test cohort to assess the predictive power of the model from May 1, 2022, to May 31, 2023.The inclusion criteria included: 1) histologically proven primary breast cancer without distant metastatic lesions, 2) HER2-positive status (defined as immunohistochemistry (IHC) of 3+ overexpression or 2+ expression, and a ratio of ≥ 2.0 by fluorescence in situ hybridization), 3) initial axillary lymph node-positive status confirmed using core- or fine-needle biopsy before NST, 4) a full course of standard neoadjuvant therapy before surgery, and 5) complete clinicopathological characteristics and treatment information. The study was approved by ethics committee of Fujian Medical University Union Hospital. All patients in the training and validation cohorts underwent mastectomy, breast-conserving surgery, radiation, and ALND surgery after completing NST. All patients in the additional independent cohort underwent SLNB followed by ALND, which detected at least 2 SLNs using methylene blue dye alone. SLNs were defined as blue-stained lymph nodes guided directly by blue-stained lymphatic vessels. Methylene blue dye was injected alone at peritumoral or subareolar sites 5-15 min before SLNB. After constructing the nomogram for predicting axillary pCR with the independent predictive factors, the investigators quantified the predictive performance of the model using the AUC of the receiver operating characteristic curve. Calibration plots with bootstrapping and the Hosmer-Lemeshow test were used to illustrate the calibration power of the model, with p > 0.05 indicating a good fit.20 The clinical utility of the model in guiding surgical options was evaluated using decision curve analysis by plotting net benefits.21 Internal validation was estimated using the bootstrap method. The investigators validated the nomogram using an external validation cohort from the other institutions. Following the Youden index, the investigators selected an optimal cutoff probability of predicting axillary pCR as a stratification criterion for identifying patients who underwent SLNB surgery after NST. The investigators additionally examined 119 patients who underwent SLNB with ≥ 2 SLNs removed, followed by ALND, as an independent cohort to evaluate the effect of the nomogram on identifying patients accurately. FNRs of SLNB were compared using two different strategies: performing SLNB in all patients without any selection criteria and performing SLNB in patients selected by the nomogram with the cutoff probability of axillary pCR. These results were compared with those of the two previous tests.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | –Patients (n=386) who accepted neoadjuvant systemic therapy followed surgery were from fujian medical university union hospital from April 1, 2012, to May 30, 2022. |
| External validation cohort | – | –Patients (n=211) who accepted neoadjuvant systemic therapy followed surgery were from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University and No. 900 Hospital of The Joint Logistic Support Force from April 1, 2012, to May 30, 2022. |
| Test cohort | – | Procedure: Test cohortPatients (n=119) who accepted sentinel lymph node biopsy followed axillary lymph node dissection after neoadjuvant systemic therapy was retrospectively collected from June 1,2022 to May 31, 2023. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators retrospectively reviewed the medical records of 597 patients at four institutions from April 1, 2012, to May 30, 2022. Patients from institution 1 (n = 386) served as the training cohort, whereas those from the other institutions (n = 211) served as an external validation cohort. A test cohort (n=119) who accepted SLNB followed ALND was collected to assess the predictive power of the model ，from June 1,2022 to We retrospectively reviewed the medical records of patients from Fujian Medical University Union Hospital (n = 386) as the training cohort and those from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, and No. 900 Hospital of The Joint Logistic Support Force (n = 211) as an external validation cohort from April 1, 2012, to March 31, 2022. Additionally, 119 patients were enrolled as the test cohort to assess the predictive power of the model from May 1, 2022, to May 31, 2023.
Key inclusion criteria (5 listed)
- histologically proven primary breast cancer without distant metastatic lesions,
- HER2-positive status (defined as immunohistochemistry (IHC) of 3+ overexpression or 2+ expression, and a ratio of ≥ 2.0 by fluorescence in situ hybridization),
- initial axillary lymph node-positive status confirmed using core- or fine-needle biopsy before NST,
- a full course of standard neoadjuvant therapy before surgery
- complete clinicopathological characteristics and treatment information.
Key exclusion criteria (5 listed)
- do not plan or are unable to operate;
- with distant metastasis
- do not accept full cycles or standard neoadjuvant systemic therapy
- loss of clinicopathological characteristics and treatment information.
- with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non-tumor related diseases who could not tolerate comprehensive treatment such as surgery and chemotherapy
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 |
|---|---|---|
| Test cohort | Procedure or surgery | Test cohort |
Primary outcome
Axillary pCR
Time frame: 10 years
the percent of patients who achieved axillary pathological complete response after NST.
1 secondary outcome
the False Negative Rate of SLNB
Time frame: 12 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 13 Dec 2023.
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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.
China Fujian principal investigator
Fujian Medical University Union 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 and Sentinel Lymph Node, run by Fujian Medical University Union 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 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 13 Dec 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?
Axillary pCR (time frame: 10 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 13 Dec 2023.