RISAS Procedure in Node Positive Breast Cancer Following NAC

Conditions

Axillary Lymph Nodes, Breast Neoplasm, Neoadjuvant Therapy, Pathological Complete Response

Brief summary

Chemotherapy in clinically node positive breast cancer patients is increasingly administrated in a neoadjuvant setting. The standard treatment regimen in these cases is then: neoadjuvant chemotherapy (NAC) followed by breast surgery and an axillary lymph node dissection (ALND). NAC results in axillary pathologic complete response (pCR) in 1 out of 3 patients, indicating a complete absence of axillary metastases after completion of NAC. In such events, ALND can be regarded as overtreatment that creates unnecessary morbidity. Less invasive axillary surgery which can accurately assess axillary pCR is therefore preferred over standard ALND in all patients. In case of detection of remaining axillary lymph node metastases by this less invasive axillary surgical procedure, completion axillary treatment is standard of care. The novel RISAS procedure is introduced as a possible less invasive axillary staging procedure. RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure. The iodine seed in the axillary lymph node metastasis will be placed prior to start of NAC.

Florien J G van Amstel, Cornelis M. de Mooij, Janine M. Simons, Cristina Mitea, P. J. van Diest et al. (37 authors)

British journal of surgery2024-08-302 citations

10.1093/bjs/znae203

Surgical Management of the Axilla in Clinically Node-Positive Breast Cancer Patients Converting to Clinical Node Negativity through Neoadjuvant Chemotherapy: Current Status, Knowledge Gaps, and Rationale for the EUBREAST-03 AXSANA Study.

Banys-Paluchowski M, Gasparri ML, de Boniface J, Gentilini O, Stickeler E, Hartmann S, Thill M, Rubio IT, Di Micco R, Bonci EA, Niinikoski L, Kontos M, Karadeniz Cakmak G, Hauptmann M, Peintinger F, Pinto D, Matrai Z, Murawa D, Kadayaprath G, Dostalek L, Nina H, Krivorotko P, Classe JM, Schlichting E, Appelgren M, Paluchowski P, Solbach C, Blohmer JU, Kühn T, The Axsana Study Group.

2021-03-29112 citations

10.3390/cancers13071565

Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS): study protocol for a multicenter, randomized phase-III trial.

Henke G, Knauer M, Ribi K, Hayoz S, Gérard MA, Ruhstaller T, Zwahlen DR, Muenst S, Ackerknecht M, Hawle H, Fitzal F, Gnant M, Mátrai Z, Ballardini B, Gyr A, Kurzeder C, Weber WP.

2018-12-04108 citations

10.1186/s13063-018-3021-9

Interventions

PROCEDURERISAS

RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Female patient with pathologically confirmed axillary lymph node positive invasive primary breast cancer, treated with neoadjuvant chemotherapy * Willing and able to undergo all study procedures. * Has personally provided written informed consent.

Exclusion criteria

* Age \< 18 * Pregnancy or lactation * Contra indications for undergoing iodine seed placement or sentinel lymph node biopsy, such as allergic reaction on iodine, 99m Technetium or patent blue. * Recurrent breast cancer * Previous axillary surgery or radiotherapy * Patients with periclavicular lymph node metastases (cN3) * Patients with advanced breast cancer (i.e. patients with distant metastases, treated without any furter surgical procedures)

Design outcomes

Primary

Measure	Time frame
Identification rate and accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of RISAS-procedure for identifying axillary pCR, with 95% confidence intervals will be calculated.	Participants will be followed from the moment of first out-hospital clinic visit untill final breast surgery, an expected average of 4 months.

Secondary

Measure	Time frame
The identification rate and accuracy (sensitivity, NPV and FNR) of both techniques used in RISAS-procedure (i.e. SLNB and MARI) for identifying axillary pCR, will be calculated separately as well.	Participants will be followed from the moment of first out-hospital clinic visit untill final breast surgery, an expected average of 4 months.

Countries

Netherlands

Outcome results

None listed