Breast CancerSOAPETNCT04072653
Sentinel Node Biopsy Vs Observation After Axillary PET
A study testing SLNB is spared in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. Based on the routine axillary imaging evaluation (ultrasound and MR etc.) and latest dedicate lymph node PET (LymphPET), axillary nodal burden can be identified before… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SLNB is spared
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,528 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2019to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage 1:
- female
- ≥18 years old
- invasive ductal carcinoma or DCIS proved by core needle biopsy
- tumor size ≤ 5cm
- negative preoperative axillary assessment(including body examination, ultrasound and MR examination)
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- patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection)
- stage 2:
- female
- ≥18 years old
- invasive carcinoma proved by core needle biopsy
- has plan for breast conserving surgery and adjuvant radiation after surgery
- negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV<0.27)
- patients is accessible for the follow up
Who cannot join
- stage 1:
- distant metastases
- in the procedure of neoadjuvant therapy
- positive preoperative axillary assessment (including body examination, ultrasound and MR examination)
- pregnancy or breastfeeding
- axillary biopsy or axillary surgery before LymphPET
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- suffer from diabetes mellitus and without well control of bloodglucose
- previous malignancy
- allergic to tracer of LymphPET
- stage 2:
- distant metastases
- in the procedure of neoadjuvant therapy
- positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27)
- pregnancy or breastfeeding
- axillary biopsy or axillary surgery before LymphPET
- suffer from diabetes mellitus and without well control of bloodglucose
- previous malignancy
- allergic to tracer of LymphPET
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhiming Shao, +86-021-64175590
About this study
Official title: Sentinel Node Biopsy Vs Observation After Axillary PET Examination
Several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. Based on the routine axillary imaging evaluation (ultrasound and MR etc.) and latest dedicate lymph node PET (LymphPET), axillary nodal burden can be identified before operation.
Therefore this prospective study are designed to evaluate the negative predictive value of LymphPET and to verify whether sentinel lymph node biopsy can be spared in patients with negative preoperative axillary assessment.
- Conditions
- Breast Cancer
- Being tested
- SLNB is spared
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLNB is sparedProcedure or surgery
SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)
| Study group | Role | What they receive |
|---|---|---|
| Observation group( SLNB is spared) | Experimental | In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment. Receives: Procedure: SLNB is spared |
What is being measured
The primary outcome is the main question the study is designed to answer.
stage 1: negative predictive value
negative predictive value of LymphPET in breast cancer patients with a negative preoperative axillary assessment
Measured: 6 months
stage 2: D-DFS(distant disease-free survival)
D-DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared
Measured: 5 years
stage 2: LRFS(local-regional free survival)
LRFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared
Measured: 5 years
Secondary outcomes (5)
stage 1: false negative rate
false negative rate of LymphPET in breast cancer patients with a negative preoperative axillary assessment
Measured: 6 months
stage 2: DFS(disease-free survival)
DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared
Measured: 5 years
stage 2: OS(overall survival)
OS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared
Measured: 5 years
stage 2: adverse events of upper limbs
adverse events of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared，as assessed by CTCAE v5.0
Measured: 5 years
stage 2: breast self evaluation
breast self evaluation for patients with negative preoperative axillary and for whom axillary surgery is spared, as assessed by BREAST Q© index. The BREAST-Q has a modular, procedure-specific structure with scales that evaluate both satisfaction and quality of life. Psychometric evaluation reveals high reliability, validity and responsiveness to surgical intervention across all scales. Breast Q is composed of aesthetical and emotional modules, and each score ranges from 1 to 4 points (higher values represent a better self evaluation). By comparing the sum of the score in different modules before and after the surgery, Breast Q can help to facilitate a self evaluation for breast cancer patients.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start4 Sep 2019
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In the first stage, the negative predictive value is evaluated in patients with negative preoperative axillary assessment, including LymphPET and routine imaging examinations. In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.
- Masking
- None (open label)
- Enrolment
- 1,528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhi-Min Shao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072653
- Sponsor's protocol ID
- SCHBCC-SOAPET
- Acronym
- SOAPET
- Status last verified
- Jul 2020
- First submitted
- 23 Aug 2019
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qu FL, Cheng JY, Jiang SH, Zhang Q, Liu GY, Cao AY, Wu J, Yu KD, Di GH, Li JJ, Shao ZM. Omission of Axillary Surgery in Patients with Negative Axillary Evaluation Integrated with LymphPET: A Prospective Clinical Study. Ann Surg Oncol. 2026 Jun;33(6):5558-5566. doi: 10.1245/s10434-026-19342-5. Epub 2026 Feb 27.
PubMed 41760969
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Biopsy Vs Observation After Axillary PET Examination
- ClinicalTrials.gov ID
- NCT04072653
- Acronym / sponsor ID
- SOAPET / SCHBCC-SOAPET
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,528 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 28 Aug 2019 (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.
Several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. Based on the routine axillary imaging evaluation (ultrasound and MR etc.) and latest dedicate lymph node PET (LymphPET), axillary nodal burden can be identified before operation.
Therefore this prospective study are designed to evaluate the negative predictive value of LymphPET and to verify whether sentinel lymph node biopsy can be spared in patients with negative preoperative axillary assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In the first stage, the negative predictive value is evaluated in patients with negative preoperative axillary assessment, including LymphPET and routine imaging examinations. In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.
| Arm | Type | Receives |
|---|---|---|
| Observation group( SLNB is spared) | Experimental | Procedure: SLNB is sparedIn the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- female
- ≥18 years old
- invasive ductal carcinoma or DCIS proved by core needle biopsy
- tumor size ≤ 5cm
- negative preoperative axillary assessment(including body examination, ultrasound and MR examination)
Key exclusion criteria (18 listed)
- distant metastases
- in the procedure of neoadjuvant therapy
- positive preoperative axillary assessment (including body examination, ultrasound and MR examination)
- pregnancy or breastfeeding
- axillary biopsy or axillary surgery before LymphPET
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 |
|---|---|---|
| SLNB is sparedSLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations) | Procedure or surgery | Observation group( SLNB is spared) |
Primary outcome
stage 1: negative predictive value
Time frame: 6 months
negative predictive value of LymphPET in breast cancer patients with a negative preoperative axillary assessment
stage 2: D-DFS(distant disease-free survival)
Time frame: 5 years
D-DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared
stage 2: LRFS(local-regional free survival)
Time frame: 5 years
LRFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared
5 secondary outcomes
stage 1: false negative rate
Time frame: 6 months
stage 2: DFS(disease-free survival)
Time frame: 5 years
stage 2: OS(overall survival)
Time frame: 5 years
stage 2: adverse events of upper limbs
Time frame: 5 years
stage 2: breast self evaluation
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Derived from this study: PubMed 41760969Qu FL, Cheng JY, Jiang SH, Zhang Q, Liu GY, Cao AY, Wu J, Yu KD, Di GH, Li JJ, Shao ZM. Omission of Axillary Surgery in Patients with Negative Axillary Evaluation Integrated with LymphPET: A Prospective Clinical Study. Ann Surg Oncol. 2026 Jun;33(6):5558-5566. doi: 10.1245/s10434-026-19342-5. Epub 2026 Feb 27.
- 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.
Zhi-Min Shao principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLNB is spared in people with Breast Cancer, run by Fudan 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 14 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 13 Jul 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Min Shao (086-021-64175590, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stage 1: negative predictive value (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072653, which also lists 1 linked publication.
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 Jul 2020.