|

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

RECRUITINGSponsored by Maastricht University Medical Center
Actively Recruiting
SponsorMaastricht University Medical Center
Started2020-07-16
Est. completion2027-07-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

Summary

Today, the majority of clinically node positive (cN+) breast cancer patients is treated with neoadjuvant systemic therapy (NST). Axillary staging and treatment after NST in cN+ patients are areas of controversy. Patients with a pathological complete response (pCR) of the axillary lymph nodes are not expected to benefit from axillary lymph node dissection (ALND). Hence, less invasive axillary staging procedures are being introduced to avoid unnecessary ALND. However, evidence supporting the safety of replacing ALND by less invasive techniques in terms of oncologic safety and impact on quality of life (QoL) is lacking.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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)

Conditions4

Breast CancerCancerLymph Node MetastasesNeoadjuvant Therapy

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.