NCT04889924 ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
| NCT ID | NCT04889924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari de Bellvitge |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 820 participants |
| Start Date | 2021-06-11 |
| Primary Completion | 2026-12-31 |
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
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 820 participants in total. It began in 2021-06-11 with a primary completion date of 2026-12-31.
⚠ 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
In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.
Eligibility Criteria
Inclusion Criteria: * T1-T4 N0/ T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment * Post-CT SLN with ≤2 macrometastasis/micrometastasis or ITCs * Post-CT axillary response by ultrasound or MRI * Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment. Exclusion Criteria: * cN2 * ypN0 * History of breast surgery for ipsilateral cancer in the last 10 years * History of other cancer in the last 5 years, except squamous carcinoma of the skin.
Contact & Investigator
Maria Laplana, MDPhD
PRINCIPAL INVESTIGATOR
Hospital Clínico y Provincial de Barcelona
Frequently Asked Questions
Who can join the NCT04889924 clinical trial?
This trial is open to participants of all sexes, 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 NCT04889924 currently recruiting?
Yes, NCT04889924 is actively recruiting participants. Contact the research team at agarciat@bellvitgehospital.cat for enrollment information.
Where is the NCT04889924 trial being conducted?
This trial is being conducted at Sydney, Australia, Sydney, Australia, Sydney, Australia, Sydney, Australia and 11 additional locations.
Who is sponsoring the NCT04889924 clinical trial?
NCT04889924 is sponsored by Hospital Universitari de Bellvitge. The principal investigator is Maria Laplana, MDPhD at Hospital Clínico y Provincial de Barcelona. The trial plans to enroll 820 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.