Invasive Breast CancerNCT03381092
Sentinel Lymph Node Biopsy in Clinically Node-negative Early Breast Cancer Patients After Neoadjuvant Chemotherapy
An observational study of Invasive Breast Cancer, run by Peking University at 1 site in China.
Trial summary
This is a prospective, single-center, non-randomized, non-controlled observational study. Read more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Invasive Breast Cancer
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2017to 30 Jun 2022
- 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 Up to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Invasive breast cancer patients with clinically negtive axilla.
Who may be able to join
- Invasive breast cancer diagnosed with core needle needle biopsy;
- Staging cT1b-2N0M0;
- ER/PR positive cells ratio <10%, or HER2 positive (according to ASCO-CAP guidelines),and with chemotherapy indications;
- Without chemotherapy contraindications, and planned or has started neoadjuvant chemotherapy (HER2 positive breast cancer neoadjuvant anti-HER2 treatment, or have adjuvant anti-HER2 treatment plan);
- With axillary sentinel lymph node biopsy indications confirmed prior to neoadjuvant therapy;
- Voluntarily join the study and sign an informed consent form.
Who cannot join
- History of malignant tumors.
- With chemotherapy contraindications.
- Recieved any form of surgery of primary tumor or axillary lymph nodes.
- Refuse neoadjuvant chemotherapy.
- Refuse assessment examinations.
- Refuse to join the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Qi-jun Zheng, MD, 0086-10-88271119 ext. 8018, 13466552347@139.com
Ying-jian He, MD, 0086-10-88271119 ext. 8018, mimi487@163.com
About this study
This is a prospective, single-center, non-randomized, non-controlled observational study.
Read the detailed description
The panel of the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017 strongly believed that sentinel lymph node biopsy to be appropriate and favored the biopsy be carried out after neoadjuvant treatment in patients who presented with a clinically negative axilla and who received neoadjuvant treatment.
Patients with clinically node-negative early breast cancer treated in Breast Cancer Prevention and Treatment Center Peking University Cancer Hospital from February 2013 to August 2017 were retrospectively analyzed to investigate whether sentinel lymph node (SLN) biopsy after neoadjuvant chemotherapy can reduce the positive rate of SLN and the rate of axillary lymph node dissection (ALND). The study group underwent SLN biopsy after neoadjuvant chemotherapy, and the control group underwent SLN biopsy before chemotherapy. A total of 395 patients were eligible, including 85 in the study group and 310 in the control group. The detection rate of SLNs was 95.3% vs 98.7%（χ2 = 3.922，P = 0.069） in the study group compared with the control group, the positive rate of SLNs was 1.2% vs 18.6%（χ2 = 15.207，P = 0.000）, and the rate of ALND was 5.9% vs 15.2%（χ2 = 5.024，P = 0.025） in univariate analysis. Multivariate analysis showed that the study group had lower SLN positive rate (OR = 0.052, 95% CI: 0.0070 to 0.38, P = 0.004) and ALND rate (OR = 0.310, 95% CI: 0.118 to 0.812, P = 0.017). There was no statistically significant difference in detection rate of SLNs （OR = 0.244, 95% CI: 0.058 to 1.021, P = 0.053）between the two groups.
The aim of this study is to explore the detection rate and positive rate of sentinel lymph nodes, the rate of axillary lymph node dissection, and the proportion of patients with axillary lymph node metastases after neoadjuvant chemotherapy in patients with clinically node-negative early breast cancer. A mathematical model of axillary lymph node status will be established to predict axillary lymph node metastases.
- Conditions
- Invasive Breast Cancer
- Keywords
- neoadjuvant chemotherapy, sentinel lymph node biopsy, axillary lymph node dissection, Predictive model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| invasive breast cancer | Patients with invasive breast cancer who have clinically negative axilla and receive neoadjuvant treatment followed by sentinel lymph node biopsy are eligible for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Rate of Axillary Sentinel Lymph Nodes.
Positive rate of axillary sentinel lymph nodes in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.
Measured: Within 6 weeks after obtaining the post-surgery pathological results.
Secondary outcomes (4)
Detection Rate of Axillary Sentinel Lymph Nodes.
Detection rate of axillary sentinel lymph nodes in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.
Measured: Within 6 weeks after obtaining the post-surgery pathological results.
Rate of Axillary Lymph Node Dissection.
Rate of axillary lymph node dissection in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.
Measured: Within 6 weeks after obtaining the post-surgery pathological results.
Proportion of Patients with Axillary Lymph Node Metastases.
Proportion of patients with axillary lymph node metastases in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.
Measured: Within 6 weeks after obtaining the post-surgery pathological results.
Axillary Lymph Nodes Status Prediction Model.
A mathematical model of axillary lymph node status will be established to predict axillary lymph node metastases in patients with early stage axillary cancer after neoadjuvant chemotherapy.
Measured: Within 6 weeks after obtaining the post-surgery pathological results.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start22 Dec 2017
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive 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
- Prospective
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao OUYANG, Peking University
- Investigators
- Qi-jun Zheng, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381092
- Sponsor's protocol ID
- BCP21
- Status last verified
- Nov 2021
- First submitted
- 4 Dec 2017
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy in Clinically Node-negative Early Breast Cancer Patients After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03381092
- Acronym / sponsor ID
- BCP21
- Conditions
- Invasive Breast Cancer
- Keywords
- neoadjuvant chemotherapy, sentinel lymph node biopsy, axillary lymph node dissection, Predictive model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 21 Dec 2017 (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 prospective, single-center, non-randomized, non-controlled observational study.
Detailed description
The panel of the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017 strongly believed that sentinel lymph node biopsy to be appropriate and favored the biopsy be carried out after neoadjuvant treatment in patients who presented with a clinically negative axilla and who received neoadjuvant treatment.
Patients with clinically node-negative early breast cancer treated in Breast Cancer Prevention and Treatment Center Peking University Cancer Hospital from February 2013 to August 2017 were retrospectively analyzed to investigate whether sentinel lymph node (SLN) biopsy after neoadjuvant chemotherapy can reduce the positive rate of SLN and the rate of axillary lymph node dissection (ALND). The study group underwent SLN biopsy after neoadjuvant chemotherapy, and the control group underwent SLN biopsy before chemotherapy. A total of 395 patients were eligible, including 85 in the study group and 310 in the control group. The detection rate of SLNs was 95.3% vs 98.7%（χ2 = 3.922，P = 0.069） in the study group compared with the control group, the positive rate of SLNs was 1.2% vs 18.6%（χ2 = 15.207，P = 0.000）, and the rate of ALND was 5.9% vs 15.2%（χ2 = 5.024，P = 0.025） in univariate analysis. Multivariate analysis showed that the study group had lower SLN positive rate (OR = 0.052, 95% CI: 0.0070 to 0.38, P = 0.004) and ALND rate (OR = 0.310, 95% CI: 0.118 to 0.812, P = 0.017). There was no statistically significant difference in detection rate of SLNs （OR = 0.244, 95% CI: 0.058 to 1.021, P = 0.053）between the two groups.
The aim of this study is to explore the detection rate and positive rate of sentinel lymph nodes, the rate of axillary lymph node dissection, and the proportion of patients with axillary lymph node metastases after neoadjuvant chemotherapy in patients with clinically node-negative early breast cancer. A mathematical model of axillary lymph node status will be established to predict axillary lymph node metastases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| invasive breast cancer | – | –Patients with invasive breast cancer who have clinically negative axilla and receive neoadjuvant treatment followed by sentinel lymph node biopsy are eligible for this study. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Invasive breast cancer patients with clinically negtive axilla.
Key inclusion criteria (6 listed)
- Invasive breast cancer diagnosed with core needle needle biopsy;
- Staging cT1b-2N0M0;
- ER/PR positive cells ratio <10%, or HER2 positive (according to ASCO-CAP guidelines),and with chemotherapy indications;
- Without chemotherapy contraindications, and planned or has started neoadjuvant chemotherapy (HER2 positive breast cancer neoadjuvant anti-HER2 treatment, or have adjuvant anti-HER2 treatment plan);
- With axillary sentinel lymph node biopsy indications confirmed prior to neoadjuvant therapy;
Key exclusion criteria (6 listed)
- History of malignant tumors.
- With chemotherapy contraindications.
- Recieved any form of surgery of primary tumor or axillary lymph nodes.
- Refuse neoadjuvant chemotherapy.
- Refuse assessment examinations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive Rate of Axillary Sentinel Lymph Nodes.
Time frame: Within 6 weeks after obtaining the post-surgery pathological results.
Positive rate of axillary sentinel lymph nodes in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.
4 secondary outcomes
Detection Rate of Axillary Sentinel Lymph Nodes.
Time frame: Within 6 weeks after obtaining the post-surgery pathological results.
Rate of Axillary Lymph Node Dissection.
Time frame: Within 6 weeks after obtaining the post-surgery pathological results.
Proportion of Patients with Axillary Lymph Node Metastases.
Time frame: Within 6 weeks after obtaining the post-surgery pathological results.
Axillary Lymph Nodes Status Prediction Model.
Time frame: Within 6 weeks after obtaining the post-surgery pathological results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
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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.
Qi-jun Zheng, MD principal investigator
Peking University Cancer Hospital & Institute
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 Invasive Breast Cancer, run by Peking University 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi-jun Zheng, MD (0086-10-88271119 ext. 8018, 13466552347@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Rate of Axillary Sentinel Lymph Nodes. (time frame: Within 6 weeks after obtaining the post-surgery pathological results.). 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 29 Nov 2021.