No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
1,250 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for women over 18 who have breast cancer and will have surgery to remove lymph nodes. Participants will provide answers about their quality of life and allow tests on their breast tissue to help understand lymphedema risk.
Are You a Good Fit for This Trial?
You may be able to join if
I am a female breast cancer patient over the age of 18
I consent to have a unilateral axillary lymph node dissection
I can also participate if I consent to a sentinel lymph node biopsy
I self-identify as Black or White and consent to unilateral ALND or possible ALND
You may not be able to join if
I am a male breast cancer patient
I consent to bilateral axillary surgery
I have had surgery on one or more axillary lymph nodes more than 6 months ago
I have a prior history of axillary lymph node dissection
I have not had breast surgery at MSK
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a…
This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female breast cancer patients over the age of 18
* Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if \<6 months from consent)
* Patients consenting for unilateral sentinel lymph node biopsy (SLNB) a…
Inclusion Criteria:
* Female breast cancer patients over the age of 18
* Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if \<6 months from consent)
* Patients consenting for unilateral sentinel lymph node biopsy (SLNB) and possible ALND are eligible for initial entry into the study, but will become ineligible if ALND is not performed
* Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment
* Patients who self-identify as Black or White consenting for unilateral ALND or possible ALND will be approached for enrollment onto translational study (Cohort 3)
Exclusion Criteria:
* Male breast cancer patients
* Patients consenting for bilateral axillary surgery
* Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed \>6 months from date of consent
* Patients with prior history of ALND
* Patients with no breast surgery performed at MSK
Contacts
Andrea Barrio, MD
646-888-5117
CONTACT
Babak Mehrara, MD
212-639-8639
CONTACT
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