Sentinel Lymph NodeNCT05763641
TAD After Chemotherapy in Locally Advanced Breast Cancer
An observational study of Sentinel Lymph Node and Breast Cancer, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
Trial summary
This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sentinel Lymph Node, Breast Cancer, Locally Advanced
- What is being tested?
- Target Axillary Dissection
- Type of treatment
- Surgery or procedure
- How many people
- 162 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Feb 2021to 1 Jun 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced breast cancer tumours (cN2 or T4) after Neoadjuvant chemotherapy
Who may be able to join
- Axillary lymph node metastasis proven by cytology
- Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis)
- Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria
- Neoadjuvant chemotherapy
Who cannot join
- cN3 verified by imaging tests
- N2 due to internal mammary involvement (N2b).
- Tumors whose surrogate molecular subtype is luminal A.
- Patients undergoing neoadjuvant endocrine therapy
- Patients with local recurrences and metastatic tumors.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clínico y Provincial de Barcelona
Barcelona, 08036
Isaac Cebrecos, MD, CEBRECOS@clinic.cat
- Recruiting
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Amparo Garcia-Tejedor, MDPhD, 0034-660223417, agarciat@bellvitgehospital.cat
About this study
Official title: Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).
Read the detailed description
The procedure will consist of marking the pathological lymph node with 1 clip before the start of neoadjuvant chemotherapy (NAC) and performing surgery after completing the NAC. The TAD will include the exeresis of the node marked with a clip, and of the sentinels marked with technetium and/or patent blue, seeking to obtain at least 3 lymph nodes. Subsequently, the axillary lymphadenectomy will be completed to identify the false negative rate. An initial analysis will be carried out with the first 30 cases, and if there are more than 2 false negative cases, it will be completed until 81 cases of TAD without associated disease are obtained.
- Conditions
- Sentinel Lymph Node, Breast Cancer, Locally Advanced
- Being tested
- Target Axillary Dissection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target Axillary DissectionProcedure or surgery
TAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
TAD validation in locally advanced breast cancer
False negative rate when performing TAD after NAC
Measured: 3 years
Secondary outcomes (2)
Ultrasound validity to evaluate axillary response after NAC
False-negative and positive rates of axillary ultrasound after NAC to assess lymph node response
Measured: 3 years
MRI validity to evaluate axillary response after NAC
False-negative and positive rates of axillary MRI after NAC to asses lymph node response
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Feb 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph NodeStudies 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
- 162 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge
- Investigators
- amparo Garcia-Tejedor, MDPhD, Principal investigator, Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763641
- Sponsor's protocol ID
- PR351/20
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05763641
- Acronym / sponsor ID
- PR351/20
- Conditions
- Sentinel Lymph Node, Breast Cancer, Locally Advanced
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 10 Mar 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.
This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and/or cT4).
Detailed description
The procedure will consist of marking the pathological lymph node with 1 clip before the start of neoadjuvant chemotherapy (NAC) and performing surgery after completing the NAC. The TAD will include the exeresis of the node marked with a clip, and of the sentinels marked with technetium and/or patent blue, seeking to obtain at least 3 lymph nodes. Subsequently, the axillary lymphadenectomy will be completed to identify the false negative rate. An initial analysis will be carried out with the first 30 cases, and if there are more than 2 false negative cases, it will be completed until 81 cases of TAD without associated disease are obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced breast cancer tumours (cN2 or T4) after Neoadjuvant chemotherapy
Key inclusion criteria (4 listed)
- Axillary lymph node metastasis proven by cytology
- Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis)
- Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria
- Neoadjuvant chemotherapy
Key exclusion criteria (5 listed)
- cN3 verified by imaging tests
- N2 due to internal mammary involvement (N2b).
- Tumors whose surrogate molecular subtype is luminal A.
- Patients undergoing neoadjuvant endocrine therapy
- Patients with local recurrences and metastatic tumors.
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 |
|---|---|---|
| Target Axillary DissectionTAD after neoadjuvant chemotherapy and subsequent axillary lymph node dissection | Procedure or surgery | – |
Primary outcome
TAD validation in locally advanced breast cancer
Time frame: 3 years
False negative rate when performing TAD after NAC
2 secondary outcomes
Ultrasound validity to evaluate axillary response after NAC
Time frame: 3 years
MRI validity to evaluate axillary response after NAC
Time frame: 3 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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
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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.
amparo Garcia-Tejedor, MDPhD principal investigator
Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sentinel Lymph Node and Breast Cancer, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
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 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 Amparo García-Tejedor, MDPhD (0034-932607702 ext. 2812, agarciat@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAD validation in locally advanced breast cancer (time frame: 3 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 17 Sep 2026.