NCT04486495 Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer
| NCT ID | NCT04486495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 549 participants |
| Start Date | 2020-07-16 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 549 participants in total. It began in 2020-07-16 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Marjolein Smidt, MD, PhD
PRINCIPAL INVESTIGATOR
Maastricht University Medical Center
Frequently Asked Questions
Who can join the NCT04486495 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04486495 currently recruiting?
Yes, NCT04486495 is actively recruiting participants. Contact the research team at s.dewild@maastrichtuniversity.nl for enrollment information.
Where is the NCT04486495 trial being conducted?
This trial is being conducted at 's-Hertogenbosch, Netherlands, Alkmaar, Netherlands, Amsterdam, Netherlands, Apeldoorn, Netherlands and 11 additional locations.
Who is sponsoring the NCT04486495 clinical trial?
NCT04486495 is sponsored by Maastricht University Medical Center. The principal investigator is Marjolein Smidt, MD, PhD at Maastricht University Medical Center. The trial plans to enroll 549 participants.
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