Breast Cancer FemaleCLYPNCT07828925
Selective Axillary Dissection After Neoadjuvant Chemotherap Yin Patients With Lymphnode-positive Breast Cancer
An observational study of Breast Cancer Female, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of this observational study is to collect data regarding the selective axillary dissection tecnique of lymphnode restaging after neoadjuvant chemotherapy in patients with Breast Cancer that is lymphonode positive at the time of the diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2018to 30 Sep 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female Patients in both pre and post menopausal stage with a diagnosis of Lymphonode Positive Breast Cancer that have to undergo to neoadjuvant chemotherapy
Who may be able to join
- Age>= 18 years
- Female sex
- Diagnosis of Lymph Node- Positive (cN+) Breast Cancer through core needle biopsy, cT1-3 (multifocal too)
- Absence of distant metastases (M0)
- Patients that will undergo to NACT
Who cannot join
- Previous diagnosis of Breast Cancer
- Previous Breast and/or Axillary Surgery
- Pregnancy
- Inflammatory Breast Cancer (cT4)
- Patients that will not undergo to NACT
Trial locations and contacts
1 site in 1 country.
Italy1 site
Radiology Department- Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
About this study
Official title: Selective Axillary Dissection After Neoadjuvant Chemotherapy in Patients With Lymphnode-positive Breast Cancer
The aim of this observational study is to collect data regarding the selective axillary dissection tecnique of lymphnode restaging after neoadjuvant chemotherapy in patients with Breast Cancer that is lymphonode positive at the time of the diagnosis.
- Conditions
- Breast Cancer Female
- Keywords
- Breast Cancer, Axillary Dissection, Sentinel Lymph Node
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients where the lymph node containing the clip does not match the sentinel lymph node
To verify the number Number of patients where the lymph node containing the clip does not match the sentinel
Measured: From enrolment until Surgery Time
Secondary outcomes (2)
Number of Patients that will not undergo to Selective Axillary Dissection
To assess Number of Patients that will not undergo to Selective Axillary Dissection
Measured: From enrolment until Surgery Time
Number of preoperative correct identification of the lymph node with the clip
To assess the match between preoperative identification of the lymph node and the lymph node with clip at surgery time
Measured: From enrolment until Surgery Time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start22 Feb 2018
- Primary completion17 Feb 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Belli, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828925
- Sponsor's protocol ID
- 1897
- Acronym
- CLYP
- Status last verified
- Sep 2026
- First submitted
- 8 Mar 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Axillary Dissection After Neoadjuvant Chemotherapy in Patients With Lymphnode-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07828925
- Acronym / sponsor ID
- CLYP / 1897
- Conditions
- Breast Cancer Female
- Keywords
- Breast Cancer, Axillary Dissection, Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 18 Sep 2026 (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 this observational study is to collect data regarding the selective axillary dissection tecnique of lymphnode restaging after neoadjuvant chemotherapy in patients with Breast Cancer that is lymphonode positive at the time of the diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female Patients in both pre and post menopausal stage with a diagnosis of Lymphonode Positive Breast Cancer that have to undergo to neoadjuvant chemotherapy
Key inclusion criteria (5 listed)
- Age>= 18 years
- Female sex
- Diagnosis of Lymph Node- Positive (cN+) Breast Cancer through core needle biopsy, cT1-3 (multifocal too)
- Absence of distant metastases (M0)
- Patients that will undergo to NACT
Key exclusion criteria (5 listed)
- Previous diagnosis of Breast Cancer
- Previous Breast and/or Axillary Surgery
- Pregnancy
- Inflammatory Breast Cancer (cT4)
- Patients that will not undergo to NACT
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
Number of patients where the lymph node containing the clip does not match the sentinel lymph node
Time frame: From enrolment until Surgery Time
To verify the number Number of patients where the lymph node containing the clip does not match the sentinel
2 secondary outcomes
Number of Patients that will not undergo to Selective Axillary Dissection
Time frame: From enrolment until Surgery Time
Number of preoperative correct identification of the lymph node with the clip
Time frame: From enrolment until Surgery Time
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 18 Sep 2026.
- 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. This study is not recruiting at the moment.
Paolo Belli, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Female, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 18 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 1 site in Italy. 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?
Number of patients where the lymph node containing the clip does not match the sentinel lymph node (time frame: From enrolment until Surgery Time). 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 18 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.