Validation of TAD in HER-2 with More Than 2 Lymph Nodes

NCT06821490 | Enrolling By Invitation

• 1 other identifier: DAD-HER2
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to validate the DAT technique in patients with Her2-positive breast cancer who have more than two positive axillary lymph nodes at diagnosis. After receiving adequate oncological treatment and axillary assessment by ultrasound for complete radiological response, DAT and Berg level I and II lymphadenectomy will be performed to assess false negatives and positives, as well as their sensitivity and specificity.

Conditions

Breast Carcinoma Metastatic in Lymph Node; HER2 Positive Breast Carcinoma

Keywords

Targeted Axillary Dissection; HER2-positive breast cance; Two or more diseased axillary lymph nodes at diagnosis

Outcome Measures

Primary Outcomes (1)

• Location of the marked lymph node and the sentinel lymph node, and assessment after lymphadenectomy of number of true positives and negatives, sensitivity and specificity

  Determining the number of positive and negative nodes in targeted axillary dissection and axillary lymphadenectomy

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (2)

• Detection of the axillary lymph node marked at diagnosis and Detection of the sentinel lymph node and concordance between marked lymph node and sentinel lymph node

  From enrollment to the end of treatment at 12 months

• Number of positive lymph nodes at diagnosis

  From enrollment to the end of treatment at 12 months

Study Arms (1)

her2positive

Patients who, at diagnosis, have more than 2 affected axillary lymph nodes. Patients in whom the most caudal affected lymph node is marked. After neoadjuvant treatment, a good axillary response is evidenced by ultrasound

Procedure: Targeted axillary dissection and subsequently a lymphadenectomy

Interventions

Targeted axillary dissection and subsequently a lymphadenectomy PROCEDURE

Selective sentinel lymph node biopsy is performed, along with biopsy of the node marked at diagnosis. Subsequently, a lymphadenectomy is performed, with the three samples separated for pathological study during the same surgical procedure

her2positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with HER2+ breast cancer, with more than two affected lymph nodes at diagnosis, who receive chemotherapy. These patients have been marked at diagnosis and show a good response after neoadjuvant treatment

You may qualify if:

• ECOG 0-1 (physical condition: able to walk and live a normal life)
• Patients with early-stage breast cancer (BC) with histopathological diagnosis of HER2+ and axillary involvement.
• Patients with either positive or negative hormonal receptor expression will be included.
• Patients must have marked the pathological axillary lymph node.
• Any number of affected or suspicious lymph nodes at diagnosis is allowed.
• Patients will receive appropriate neoadjuvant treatment based on a combination of chemotherapy and anti-HER2 therapy.
• After neoadjuvant treatment and prior to surgery, radiological response will be assessed.
• No relevant comorbidities, adequate liver and kidney function, and no contraindications to receive neoadjuvant treatment followed by surgery and radiotherapy.

You may not qualify if:

• Patients with inoperable breast cancer.
• Patients with a diagnosis of inflammatory breast cancer.
• Patients without a diagnostic biopsy of the suspicious lymph node or the presence of axillary conglomerate.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico de la Comunidad Valenciana

Valencia, Valencia, 46010, Spain

Location

Related Publications (9)

• Ng S, Sabel MS, Hughes TM, Chang AE, Dossett LA, Jeruss JS. Impact of Breast Cancer Pretreatment Nodal Burden and Disease Subtype on Axillary Surgical Management. J Surg Res. 2021 May;261:67-73. doi: 10.1016/j.jss.2020.12.007. Epub 2021 Jan 6.

  PMID: 33421795 BACKGROUND

• Gasparri ML, de Boniface J, Poortmans P, Gentilini OD, Kaidar-Person O, Banys-Paluchowski M, Di Micco R, Niinikoski L, Murawa D, Bonci EA, Pasca A, Rubio IT, Karadeniz Cakmak G, Kontos M, Kuhn T. Axillary surgery after neoadjuvant therapy in initially node-positive breast cancer: international EUBREAST survey. Br J Surg. 2022 Aug 16;109(9):857-863. doi: 10.1093/bjs/znac217.

  PMID: 35766257 BACKGROUND

• Simons JM, Jacobs JG, Roijers JP, Beek MA, Boonman-de Winter LJM, Rijken AM, Gobardhan PD, Wijsman JH, Tetteroo E, Heijns JB, Yick CY, Luiten EJT. Disease-free and overall survival after neoadjuvant chemotherapy in breast cancer: breast-conserving surgery compared to mastectomy in a large single-centre cohort study. Breast Cancer Res Treat. 2021 Jan;185(2):441-451. doi: 10.1007/s10549-020-05966-y. Epub 2020 Oct 19.

  PMID: 33073303 BACKGROUND

• Galimberti V, Ribeiro Fontana SK, Vicini E, Morigi C, Sargenti M, Corso G, Magnoni F, Intra M, Veronesi P. "This house believes that: Sentinel node biopsy alone is better than TAD after NACT for cN+ patients". Breast. 2023 Feb;67:21-25. doi: 10.1016/j.breast.2022.12.010. Epub 2022 Dec 20.

  PMID: 36566690 BACKGROUND

• Cha C, Ahn SG, Kim D, Lee J, Park S, Bae SJ, Kim JY, Park HS, Park S, Kim SI, Park BW, Jeong J. Axillary response according to neoadjuvant single or dual human epidermal growth factor receptor 2 (HER2) blockade in clinically node-positive, HER2-positive breast cancer. Int J Cancer. 2021 Oct 15;149(8):1585-1592. doi: 10.1002/ijc.33726. Epub 2021 Jul 8.

  PMID: 34213778 BACKGROUND

• Bernet L, Piñero A, Martínez M, Sicart SV, Algara M, Palomares E. Consensus of the Spanish Society of Breast Senology and Pathology (SESPM) on Selective Biopsy of the Sentinel Node (BSGC) and axylar management in breast cancer (2022). Revista de Senologia y Patologia Mamaria. 2022 Oct 1;35(4):243-59.

  BACKGROUND

• Early Breast Cancer Trialists' Collaborative group (EBCTCG). Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials. Lancet Oncol. 2021 Aug;22(8):1139-1150. doi: 10.1016/S1470-2045(21)00288-6.

  PMID: 34339645 BACKGROUND

• Schettini F, Pascual T, Conte B, Chic N, Braso-Maristany F, Galvan P, Martinez O, Adamo B, Vidal M, Munoz M, Fernandez-Martinez A, Rognoni C, Griguolo G, Guarneri V, Conte PF, Locci M, Brase JC, Gonzalez-Farre B, Villagrasa P, De Placido S, Schiff R, Veeraraghavan J, Rimawi MF, Osborne CK, Pernas S, Perou CM, Carey LA, Prat A. HER2-enriched subtype and pathological complete response in HER2-positive breast cancer: A systematic review and meta-analysis. Cancer Treat Rev. 2020 Mar;84:101965. doi: 10.1016/j.ctrv.2020.101965. Epub 2020 Jan 17.

  PMID: 32000054 BACKGROUND

• Haque W, Verma V, Hatch S, Suzanne Klimberg V, Brian Butler E, Teh BS. Response rates and pathologic complete response by breast cancer molecular subtype following neoadjuvant chemotherapy. Breast Cancer Res Treat. 2018 Aug;170(3):559-567. doi: 10.1007/s10549-018-4801-3. Epub 2018 Apr 24.

  PMID: 29693228 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Head of the General Surgery Department

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 12, 2025
• Study Start: June 30, 2024
• Primary Completion: January 30, 2026
• Study Completion: February 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

ES (1)