This trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related Quality of Life (QoL) and occurrence of lymphedema two years after randomization.
Despite major morbidity, axillary lymph node dissection (ALND) is standard of care in patients with clinically node positive breast cancer (cN+ BC) who undergo upfront surgery, which is frequently indicated in case of luminal biology. Tailored axillary surgery (TAS) was shown to selectively target positive nodes, thereby removing significantly more nodes than sentinel lymph node biopsy (SLNB), but less nodes than ALND. Therefore, it is currently unclear if TAS in combination with axillary radiotherapy (ART) exposes the axilla to less harm compared to ALND. It is hypothesized that patient's quality of life (QoL) and morbidity can be improved by replacing ALND with the combination of TAS and ART in patients undergoing upfront surgery. The main goal of this trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related QoL and occurrence of lymphedema two years after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,060
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)
Axillary irradiation
Change in arm-related Quality of Life (QoL)
The arm subscale (ARM) of the FACT-B+4 is used to assess arm-related QoL.The FACT-B comprises five subscales: physical well-being (seven items), social well-being (seven items), emotional well-being (six items), functional well-being (seven items), and concerns specific to patients with breast cancer (13 items). The FACT-B+4 questionnaire consists of the FACT-B subscales and the additional ARM subscale including five questions related to arm morbidity with four additional validated arm morbidity items that are added to the one item on arm morbidity already included in the FACT-B questionnaire. Patients are asked to indicate on a five- point scale from 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), to 4 (very much), to what degree each statement applied over the previous 7 days. The individual scoring of each question is inverted and added up to the total score ranging between 0 and 20 points, higher scores representing less arm problems.
Time frame: From baseline to 2 years after randomization
Occurrence of lymphedema
Bilateral measurements will be obtained 10 cm above and 5 cm below the olecranon process on both the ipsilateral and contralateral upper extremities. The change in ipsilateral upper- extremity circumference, corrected for any change in the contralateral upper extremity, will be calculated using the following formula: L = (Ia - Ib) - (Ca- Cb). It indicates ipsilateral upper-extremity circumference, C indicates contralateral upper- extremity circumference, a indicates assessments during trial treatment and follow-up, and b indicates baseline assessment. L will be calculated for both upper arm and forearm, and lymphedema is defined as present if L \> 2 cm for either location. The proportion of patients with lymphedema will be calculated.
Time frame: From baseline to 2 years after randomization
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
NOT_YET_RECRUITINGDuke University/Duke Cancer Center
Durham, North Carolina, United States
NOT_YET_RECRUITINGFox Chase Cancer Center
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Dornbirn, Austria
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Feldkirch, Austria
NOT_YET_RECRUITINGMUI - Univ. Klinik f. Frauenheilkunde Innsbruck
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RECRUITINGOrdensklinikum Linz
Linz, Austria
NOT_YET_RECRUITINGMedical University Vienna, Department of Gynecology
Vienna, Austria
NOT_YET_RECRUITINGMedical University Vienna, Department of Surgery
Vienna, Austria
NOT_YET_RECRUITING...and 44 more locations