Breast Carcinoma Metastatic in Lymph NodeDAD-HER2NCT06821490
Validation of TAD in HER-2 with More Than 2 Lymph Nodes
An observational study of Breast Carcinoma Metastatic in Lymph Node and HER2 Positive Breast Carcinoma, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma Metastatic in Lymph Node, HER2 Positive Breast Carcinoma
- What is being tested?
- Targeted axillary dissection and subsequently a lymphadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2024to Feb 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Clínico de la Comunidad Valenciana
Valencia, Valencia, 46010
About this study
Official title: It is Possible to Reduce the Performance of Axillary Lymphadenectomies in Patients with HER2-positive Breast Cancer with a Clinically Positive Axilla At Diagnosis
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.
Read the detailed description
This study aims to determine whether axillary treatment can be further de-escalated in patients with HER2-positive breast cancer, as this group has shown good responses to certain targeted therapies. It focuses on reducing the need for extensive axillary surgery (known as axillary lymphadenectomy or AL), which can cause complications, by using a less invasive procedure called Targeted Axillary Dissection (TAD). This method combines the removal of sentinel lymph nodes and previously marked nodes, allowing for an assessment of treatment response without needing to remove all lymph nodes. Currently, this method is used in patients diagnosed with axillary disease involving fewer than two axillary nodes.
Main Objective:
To evaluate whether axillary lymphadenectomy can be avoided in HER2-positive breast cancer patients with more than two affected axillary nodes who respond well to chemotherapy before surgery.
Secondary Objectives:
Analyze the oncological treatment response in these patients. Determine how many affected nodes respond to the treatment. Evaluate whether the number of affected nodes at diagnosis limits the possibility of performing TAD.
Compare methods for locating the affected nodes. Verify the concordance between marked nodes and sentinel nodes.
Methodology:
This is a multicenter, prospective descriptive study. Women with HER2-positive breast cancer who receive chemotherapy before surgery will be included. Those who show a good axillary response will be offered the TAD procedure, followed by lymphadenectomy, to assess the sensitivity, specificity, false negatives, and true positives of the technique. Clinical and radiological data will be collected to analyze outcomes and complications.
Significance:
The TAD procedure has already allowed this hospital to reduce extensive axillary surgeries by 30%, preventing associated complications. This study seeks to confirm whether this approach is safe and effective in a specific group of HER2-positive breast cancer patients with more than two affected nodes at diagnosis. If successful, it could lead to a change in how these patients are treated, reducing risks and improving their quality of life.
- Being tested
- Targeted axillary dissection and subsequently a lymphadenectomy
- Keywords
- Targeted Axillary Dissection, HER2-positive breast cance, Two or more diseased axillary lymph nodes at diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted axillary dissection and subsequently a lymphadenectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Targeted axillary dissection and subsequently a lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Number of marked nodes that match the sentinel nodes
Measured: From enrollment to the end of treatment at 12 months
Number of positive lymph nodes at diagnosis
Number of positive lymph nodes at the time of diagnosis for which TAD (directed axillary
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start30 Jun 2024
- Primary completion30 Jan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast Carcinoma Metastatic in Lymph NodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvira Buch, Fundación para la Investigación del Hospital Clínico de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821490
- Sponsor's protocol ID
- DAD-HER2
- Acronym
- DAD-HER2
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be protected in the patient's medical record, although the patient is informed about the study and will sign a consent form. It is uncertain whether it is ethical to share the individual data.
Publications
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.
PubMed 33421795Gasparri 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.
PubMed 35766257Simons 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.
PubMed 33073303Galimberti 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.
PubMed 36566690Cha 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.
PubMed 34213778Bernet 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.
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.
PubMed 34339645Schettini 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.
PubMed 32000054Haque 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.
PubMed 29693228