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Search / Trial NCT04486495

Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Jul 22, 2020

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a less invasive approach to treating breast cancer in women who have positive lymph nodes. Many patients receive treatment called neoadjuvant systemic therapy (NST) before surgery, which can shrink tumors and improve outcomes. For women with node-positive breast cancer, the trial is exploring whether less invasive methods of checking and treating the lymph nodes after NST can be as effective as traditional surgery, which often involves removing lymph nodes. This is important because some patients may not need more invasive procedures if their lymph nodes show no signs of cancer after treatment.

To be eligible for this trial, participants must be women with one-sided invasive breast cancer and positive lymph nodes who are planning to receive NST. Certain conditions, like having previous breast cancer treatments or other types of cancer, would exclude someone from participating. If you join the trial, you can expect to undergo NST followed by tests and treatment for both the breast and the lymph nodes, with the goal of determining whether these less invasive methods can maintain safety and improve quality of life.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Female patient with unilateral invasive breast cancer and cN1-3
  • Pathologically proven positive axillary lymph node
  • Planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla
  • Exclusion Criteria:
  • Clinically node negative breast cancer before NST
  • Bilateral invasive breast cancer
  • Neoadjuvant endocrine therapy
  • Distant metastases (including oligometastatic disease)
  • History of invasive breast cancer
  • Other malignancies, except for basal/squamous cell skin cancer, and in situ carcinoma of the cervix or breast
  • Axillary surgery or radiotherapy before NST (this includes SLNB prior to NST)

About Maastricht University Medical Center

Maastricht University Medical Center (MUMC+) is a leading academic medical center in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, MUMC+ integrates cutting-edge scientific inquiry with clinical practice, focusing on a wide range of medical disciplines. The center emphasizes collaboration among multidisciplinary teams, fostering an environment that promotes excellence in patient care and the translation of research findings into clinical applications. MUMC+ is dedicated to improving health outcomes and enhancing quality of life through rigorous clinical investigations and the development of novel therapeutic strategies.

Locations

Enschede, , Netherlands

Leiden, , Netherlands

Leiden, , Netherlands

Arnhem, , Netherlands

Doetinchem, , Netherlands

Ede, , Netherlands

Hengelo, , Netherlands

Breda, , Netherlands

Rotterdam, , Netherlands

Maastricht, , Netherlands

Utrecht, , Netherlands

Eindhoven, , Netherlands

Rotterdam, , Netherlands

'S Hertogenbosch, , Netherlands

Beverwijk, , Netherlands

Amsterdam, , Netherlands

Groningen, , Netherlands

Apeldoorn, , Netherlands

Dordrecht, , Netherlands

Hilversum, , Netherlands

Rotterdam, , Netherlands

Leeuwarden, , Netherlands

Hoofddorp, , Netherlands

Rotterdam, , Netherlands

Nijmegen, , Netherlands

Bilthoven, , Netherlands

Leiderdorp, , Netherlands

Zwolle, , Netherlands

Schiedam, , Netherlands

Terneuzen, , Netherlands

Amsterdam, North Holland, Netherlands

Alkmaar, , Netherlands

Eindhoven, , Netherlands

Hardenberg, , Netherlands

Leidschendam, , Netherlands

Hoorn, , Netherlands

Dirksland, , Netherlands

Spijkenisse, , Netherlands

Patients applied

0 patients applied

Trial Officials

Marjolein Smidt, MD, PhD

Principal Investigator

Maastricht University Medical Center

Marie-Jeanne Vrancken Peeters, MD, PhD

Principal Investigator

The Netherlands Cancer Institute

Linetta Koppert, MD, PhD

Principal Investigator

Erasmus Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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