The evaluation of targeted axillary dissection with Hydromark and Guiding Marker System.

JRCT ID: jRCTs042210020

Registered date:17/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 01/06/2021
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Hydromark are placed in patients diagnosed with 1 to 3 axillary lymph node metastases prior to neoadjuvant chemotherapy (NAC).
Targeted Axillary Dissection (TAD) is performed using the Guiding Marker System for patients who have achieved yc N0 after NAC.
Axillary dissection is performed as usual for patients who could not achieve yc N0 after NAC.

Outcome(s)

Primary Outcome

1.Success rate of TAD using the guiding marker system with Hydromark
TAD is successful if all of the following are met
(1) Hydromark can be placed in metastasis-positive axillary lymph nodes
(2) Hydromark can be identified and Guiding Marker System can be inserted there, with US.
(3) Hydromark can be removed with using Guiding Marker System.
(4) Sentinel lymph node can be identified
2.Incidence of adverse events associated with hydromark placement
3.Incidence of adverse events by the guiding marker system

Secondary Outcome

1.Evaluate the following in TAD cases
(1) Presence or absence of metastasis to Targeted LNs and Non-Targeted LNs(Ax case only) (false negative of TAD)
(2) Match rate between Clipped LN and SLN
(3) Number of Targeted LNs resection
(4)Identification rate of SLNB
2. Evaluate the following in ycN + cases
(1)Presence or absence of metastasis to Clipped LN
(2)Number of metastases to other than Clipped LN

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients pathologically diagnosed with breast cancer and axillary lymph node metastasis.
2. Clinically confirmed 1 to 3 axillary lymph node metastases
3. Histological type can be anything.
4. Patients planning to receive standard neoadjuvant chemotherapy for primary breast cancer
5. Age at the time of consent is 20 years or older
6. ECOG Performance Status (PS) of 0 to 2
7. Meet all of the following criteria for organ function (within 21 days before registration)
(1) Neutrophil count >=1,500/mm3 or WBC >= 3,000/mm3
(2)Hemoglobin >= 8.0g/dL
(3) Platelet count >= 100,000/mm3
(4)Total bilirubin is 1.5 times or less of the normal upper limit
(5)AST (GOT) and ALT (GPT) <=100U/L
(6)Serum creatinine is less than 1.5 times the upper limit of normal.
8. The diseased upper limb can be lifted in the supine position.
9. Patients who submits written consent herself after receiving sufficient explanation about this study

Exclude criteria

1. Pregnant women, those with a positive pregnancy test, within 28 days after giving birth, or during lactation
2. Severe mental disease.
3. Patient who is assessed not applicable by investigator.

Related Information

• Primary Sponsor: Kotani Haruru