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New treatment option for Breast Cancer Female
Official title Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer
ClinicalTrials.gov ID: NCT04671511
What this study is testing
- What it's testing
- RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Participants must be ≥ 18 years old.
- Participants with a clinical T1 or T2 invasive ductal or lobular breast carcinoma, regardless of estrogen/progesterone/human epidermal growth factor...
- Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound.
- Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status less than 2.
You likely can't join if
- Participant with previous ipsilateral axillary surgery, including sentinel lymph node biopsy.
- Participants with distant metastases.
- Participants that have had previous radiotherapy to the axillary nodes.
- Participants who received neoadjuvant therapy.
- If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue, methylene blue or radiocolloid dye.
- Participants who are unable to provide informed consent.
See the full eligibility criteria
- Participants must be ≥ 18 years old.
- Participants with a clinical T1 or T2 invasive ductal or lobular breast carcinoma, regardless of estrogen/progesterone/human epidermal growth factor receptor 2 (HER2) receptor status.
- Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound.
- Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status less than 2.
- Participants must understand, accept, and have signed the approved consent form.
- Participant with previous ipsilateral axillary surgery, including sentinel lymph node biopsy.
- Participants with distant metastases.
- Participants that have had previous radiotherapy to the axillary nodes.
- Participants who received neoadjuvant therapy.
- If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue, methylene blue or radiocolloid dye.
- Participants who are unable to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.