Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

  • STATUS
    Recruiting
  • End date
    Jan 11, 2024
  • participants needed
    516
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 11 April 2022
breast surgery
carcinoma
carcinoma in situ
breast carcinoma
invasive breast cancer
mastectomy
ductal carcinoma in situ
lobular carcinoma in situ
sentinel lymph node biopsy
isosulfan blue
lcis

Summary

This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

Description

PRIMARY OBJECTIVES:

I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping [ARM]) versus Group II (ARM).

SECONDARY OBJECTIVES:

I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A).

II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics.

III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM.

EXPLORATORY OBJECTIVES:

I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND).

GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.

After completion of study, patients are followed up for 3 years.

Details
Condition Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Treatment questionnaire administration, quality-of-life assessment, Axillary Lymph Node Dissection, Isosulfan Blue, Mapping
Clinical Study IdentifierNCT03927027
SponsorAlliance for Clinical Trials in Oncology
Last Modified on11 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Documentation of Disease: cT1-3 patients undergoing axillary surgery who additionally meet one of the following conditions
Clinically node negative patients undergoing mastectomy and sentinel lymph node biopsy (SLNB) with possible axillary lymph node dissection (ALND) if SLNB is positive. If ALND is performed during a separate operation, ARM procedure must be repeated. Clinically node negative is defined by i) negative clinical exam and/or ii) negative axillary US and/or iii) negative needle biopsy of sonographically suspicious axillary nodes as applicable to each case
Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery
Patients will be staged according to the TNM staging system
Prior Treatment: No prior axillary surgery except needle biopsy or concurrent SLNB
Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration
No prior history of ipsilateral breast cancer (invasive or ductal breast carcinoma in
No bilateral invasive breast cancer
situ [DCIS]). Lobular breast carcinoma in situ (LCIS) and benign disease are
No matted nodes
allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks
No history of lymphedema of either arm
before registration)
No known allergies blue dyes, including make-up containing blue dye
In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English
Female
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Men are excluded from this study because the number of men with breast cancer is
Creatinine: =< 1.5 x upper limit of normal (ULN)
insufficient to provide a statistical basis for assessment of effects in this subpopulation
of people with breast cancer
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