Resumen

Este ensayo tiene como objetivo investigar si, en pacientes con cáncer de mama clínicamente con ganglios positivos sometidas a cirugía de inicio, el tratamiento con TAS y ART es superior a ALND en términos de calidad de vida (CdV) relacionada con el brazo y aparición de linfedema dos años después de la aleatorización.

Descripción detallada

A pesar de la importante morbilidad asociada, la disección de ganglios linfáticos axilares (ALND) es el estándar de atención en pacientes con cáncer de mama clínicamente con ganglios positivos (cN+ BC) que se someten a cirugía de inicio, la cual se indica con frecuencia en casos de biología luminal. Se ha demostrado que la cirugía axilar adaptada (TAS) permite identificar selectivamente los ganglios positivos, extirpando significativamente más ganglios que la biopsia de ganglio centinela (SLNB), pero menos que la ALND. Por lo tanto, actualmente no está claro si la TAS en combinación con radioterapia axilar (ART) expone la axila a menor daño en comparación con la ALND. Se plantea la hipótesis de que la calidad de vida (CdV) y la morbilidad de los pacientes pueden mejorar al reemplazar la ALND por la combinación de TAS y ART en pacientes sometidas a cirugía de inicio. El objetivo principal de este ensayo es investigar si, en pacientes con cáncer de mama clínicamente con ganglios positivos sometidas a cirugía de inicio, el tratamiento con TAS y ART es superior a ALND en términos de CdV relacionada con el brazo y aparición de linfedema dos años después de la aleatorización.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
Patients ≥ 18 years of age.
Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) American Joint Committee on Cancer/ International Union Against Cancer (AJCC/UICC) stage II-III (all molecular subtypes allowed).
Node-positivity detected by imaging and non-palpable (iN+) and confirmed by pathology.
Node-positivity palpable (cN1-3) and confirmed by pathology.
Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present.
Eligible for primary ALND or SLN procedure and either:
Newly diagnosed.
Isolated in-breast recurrence or second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure and at least 3 years disease free and no prior axillary dissection or axillary RT.
Upfront surgery setting.
Most suspicious axillary lymph node clipped. (If clipping is not part of the routine, this should be done after consent of the patient as a study procedure.)
Ability to complete the QoL questionnaires.
WHO performance status 0-2
Adequate condition for general anesthesia, breast cancer surgery and radiotherapy.
Adult patients (≥18 years of age).
Women of child-bearing potential are using effective contraception (condom, diaphragm, intrauterine device), are not pregnant or lactating and agree not to become pregnant during trial treatment (until end of RT) and thereafter during the time recommended by the guidelines - also for adjuvant systemic therapies. A negative pregnancy test before registration is required for all women of child-bearing potential.
Men agree not to father a child during trial treatment and for 6 months afterward.

Criterios de exclusión

Stage IV breast cancer.
Clinical N3c breast cancer without axillary disease (clinical N3a and clinical N3b are allowed).
Clinical N2b breast cancer (clinical N2a is allowed).
Contralateral breast cancer within 3 years.
Prior axillary surgery (except prior sentinel node procedure in case of in-breast recurrence).
Prior regional radiotherapy.
Neoadjuvant treatment with the exception of bridging therapy given for less than 3 months.
History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from pre-registration with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Absence of clip in the specimen radiography.
Palpable disease left behind in the axilla after TAS.
No SLN identified in the axilla.

Intervenciones

procedure

Axillary lymph node dissection (ALND)

Surgical removal of lymphatic tissue within the anatomical boundaries of the axilla (standard of care in the upfront surgery setting in patients with cN+ BC)

procedure

Axillary radiotherapy (ART)

Axillary irradiation

Ubicaciones

Sanatorio Parque Breast Cancer Center

Rosario, Argentina

Luciano Mignini · lmignini@gmail.com

NOT_YET_RECRUITING

Patrocinadores

PrincipalUniversity Hospital, Basel, Switzerland

Contactos

Walter P. Weber, Prof. Dr. med.

CONTACT

walter.weber@usb.ch +41 61 328 61 49

OPBC project management team