Targeted Axillary Dissection After Neo-adjuvant Chemotherapy

  • STATUS
    Recruiting
  • End date
    Jun 18, 2024
  • participants needed
    100
  • sponsor
    Universitair Ziekenhuis Brussel
Updated on 18 December 2021
metastasis
HER2
triple negative breast cancer
erbb2
adjuvant chemotherapy
axillary lymph node dissection
sentinel node

Summary

Currently most breast cancer patients with confirmed axillary lymph node metastasis (cN1) at diagnosis are candidates for neoadjuvant chemotherapy (NAC). The increased utilization of NAC can be attributed to practical clinical advantages. The increasing use of NAC has, however, introduced questions regarding appropriate loco-regional management, including the optimal surgical approach to the axillary lymph nodes.

According to current guidelines, patients presenting with cN1 disease and treated with NAC, still undergo axillary lymph node dissection (ALND). In forty percent of these patients, however, the investigators see a nodal complete pathological response (ypN0). In certain subgroups, triple negative breast cancer and Her2 amplified breast cancer, this percentage is even higher. The investigators would like to lessen surgical morbidity by performing a targeted axillary dissection. The investigators place a clip in the biopsy-proven lymph node metastasis at diagnosis. After NAC, the investigators perform a dual agent sentinel node procedure and remove the clipped node during the same surgery. When these lymph nodes are microscopically tumor-free, the investigators can abolish an ALND. Targeted axillary dissection after NAC for cN1 disease seems to have acceptable false negative rates in previous trials. The investigators would like to further define patients where an ALND can be safely omitted.

Details
Condition Breast Cancer
Treatment TAD (Targeted Axillary Dissection)
Clinical Study IdentifierNCT05071911
SponsorUniversitair Ziekenhuis Brussel
Last Modified on18 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients diagnosed with cT1-3N1M0 breast cancer, histopathologically confirmed
Age greater than or equal to 18 years and less than or equal to 85 years
Necessity and agreement to neoadjuvant chemotherapy

Exclusion Criteria

Previous surgery ipsilateral axillary or radiation ipsilateral axillary / chest
Extranodal metastases M1
cN2-3 status
Breast cancer with direct invasion of chest wall and / or skin cT4
Disease progression (clinical /radiological) under neoadjuvant treatment
Pregnancy
Presence of a pacemaker in the ipsilateral chest wall
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note