Jana de Boniface

The sentinel node, or the gatekeeper, is the first lymph node in the armpit to receive lymph from the breast, and thus also the first place where tumor cells are found if spread via lymphatics occurs in breast cancer. If the sentinel node is healthy, it is not necessary today to remove several lymph nodes from the armpit (axillary evacuation). Since axillary dissection entails a considerable risk of problems with the arm, in recent years people have begun to refrain from axillary dissection even when there is limited tumor spread to the sentinel node. However, whether this is safe has not yet been proven. The current SENOMAC study tests whether axillary evacuation needs to be done in patients with breast cancer who have tumor spread to 1-2 gatekeeper glands. The study is randomized, which means that after their sentinel node biopsy, patients are randomized to either undergo axillary dissection or to refrain from it. The study has included 2768 patients from 5 European countries in 2015-2021. Via questionnaires, the participants tell us about their quality of life and arm function. The study wants to show that you can reduce surgery in the armpit and thus reduce the occurrence of problems with the arm without worsening the prognosis. Inclusion in the study is now closed and follow-up is ongoing. With the SENOMAC study, I want to show that axillary evacuation does not need to be done in case of limited tumor spread of breast cancer to the sentinel node. Indirectly, this means that it is not the surgery itself, but rather other additional treatments, which protect against recurrence. I want to bring about a change in guidelines where surgery in the armpit is only as extensive as needed but not unnecessarily large. This needs to apply to all groups of patients, not just the sample of individuals who have participated in previous studies. With this, I want to achieve that the quality of life and arm function is improved for a large number of women.

The role of completion axillary lymph node dissection (ALND) in sentinel node (SN)-positive breast cancer is questioned since key randomized trials showed no survival differences comparing completion ALND and SN biopsy alone. These trials however were significantly underpowered, and in addition, patients undergoing mastectomy or those with larger tumors were not included. Thus, there is a need for additional prospective data validating previous results with sufficient statistical power to detect even smaller survival differences, and including the crucial subgroup of mastectomy patients. The SENOMAC trial was initiated in 2015 as an international randomized phase 3 clinical trial including patients with clinically node-negative T1-T3 breast cancer and up to two SN macrometastases. Patients are randomized 1:1 to undergo completion ALND or not, and both breast-conserving surgery and mastectomy are eligible interventions. The non-inferiority endpoint is overall survival at 5 years with a non-inferiority margin of 2.5% (94% versus 91.5%), targeting an overall accrual of 3000 patients. Secondary endpoints such as arm morbidity and health-related quality of life are measured by patient-reported outcomes (PROs) at 1, 3 and 5 years. The SENOMAC Trial has to date including 2395 patients, 34% of whom operated by mastectomy, from 5 European countries. Enrolment will be closed at the end of 2021, and the first report on the primary endpoint is expected in 2024.

Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes. The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses.712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine.

The sentinel node, or gatekeeper, is the first lymph node in the armpit to receive lymph from the breast, and thus also the first place where tumor cells gather if spread with the lymph flow occurs in breast cancer. If the sentinel node is healthy, it is not necessary today to remove several lymph nodes from the armpit (axillary evacuation). Since axillary evacuation entails a considerable risk of subsequent problems with the arm, it has in recent years begun to investigate whether it is possible to refrain from axillary evacuation even when there is microscopic tumor spread to the sentinel node. So far, the results are promising, but the data is still too small to be implemented on a broad front. The current study, dubbed SENOMAC, raises the question of whether axillary evacuation needs to be performed in patients with breast cancer who have microscopic tumor spread to the concierge. In order to obtain a scientifically high-quality answer, the study is carried out with randomization, which means that patients after their sentinel node biopsy are randomized to either undergo axillary evacuation or also refrain from it. The study is ongoing at many hospitals in 6 different European countries. The aim is to show that it is possible to limit the scope of surgery in the armpit, and thereby reduce the incidence of problems with the arm, without worsening the prognosis. With the SENOMAC study, I want to show that axillary evacuation does not need to be done by microscopic tumor spread of breast cancer to the gatekeeper (sentinel node). Indirectly, this means that it is not the surgery itself, but rather other additional treatments, that protect against relapse. I want to bring about a change in national and international guidelines where surgery in the armpit is only as extensive as needed but not unnecessarily large. This needs to apply to all groups of patients, not just the sample of individuals who have participated in previous studies. With this, I want the quality of life and arm function to be improved for a large number of women.

The sentinel node, or gatekeeper, is the first lymph node in the armpit to receive lymph from the breast, and thus also the first place where tumor cells gather if spread with the lymph flow occurs in breast cancer. If the sentinel node is healthy, it is not necessary today to remove several lymph nodes from the armpit (axillary evacuation). Since axillary evacuation entails a considerable risk of subsequent problems with the arm, it has in recent years begun to investigate whether it is possible to refrain from axillary evacuation even when there is microscopic tumor spread to the sentinel node. So far, the results are promising, but the data is still too small to be implemented on a broad front. The current study, dubbed SENOMAC, raises the question of whether axillary evacuation needs to be performed in patients with breast cancer who have microscopic tumor spread to the concierge. In order to obtain a scientifically high-quality answer, the study is carried out with randomization, which means that patients after their sentinel node biopsy are randomized to either undergo axillary evacuation or also refrain from it. The study is ongoing at many hospitals in 6 different European countries. The aim is to show that it is possible to limit the scope of surgery in the armpit, and thereby reduce the incidence of problems with the arm, without worsening the prognosis. With the SENOMAC study, I want to show that axillary evacuation does not need to be done by microscopic tumor spread of breast cancer to the gatekeeper (sentinel node). Indirectly, this means that it is not the surgery itself, but rather other additional treatments, that protect against relapse. I want to bring about a change in national and international guidelines where surgery in the armpit is only as extensive as needed but not unnecessarily large. This needs to apply to all groups of patients, not just the sample of individuals who have participated in previous studies. With this, I want the quality of life and arm function to be improved for a large number of women.

Sentinel node, or the concierge, is the first lymph node in the armpit that receives lymph from the breast, and thus also the first site where tumor cells accumulate if proliferation with the lymph flow occurs in breast cancer. If sentinel node is healthy, one does not need to remove several lymph nodes from the armpit (axillary space). Since axillary spasm causes a considerable risk of subsequent arthroplasty, the last few years have begun to investigate whether axillary space can be dispensed with even when there is microscopic tumor spread to the sentinel node. So far, the results are promising, but the data is still too small to be implemented on a broad front. The current study, which has been named SENOMAC, raises the question of the need for axillary evacuation in patients with breast cancer who have microscopic tumor spread to the concierge. In order to obtain a scientifically high-quality response, the study is carried out with randomization, which means that patients after their sentinel node biopsy are randomized to either undergo axillary clearance or also abstain from it. The study is ongoing at many hospitals both in Sweden and in Denmark. The goal is to show that one can limit the extent of the surgery in the armpit, and thus reduce the incidence of the arm, without impairing the prognosis. With the SENOMAC study, we want to show that axillary clearance does not need to be done in microscopic tumor proliferation of the breast cancer to the sentinel node. Indirectly, this means that it is not the surgery itself, but rather the usual additional treatments that protect against relapse. We want to make sure that surgery in the armpit is just as extensive as is needed but not unnecessarily large, and that the quality of life and the arm function are thereby improved for a large number of women every year.

Sentinel node, or the concierge, is the first lymph node in the armpit that receives lymph from the breast, and thus also the first site where tumor cells accumulate if proliferation with the lymph flow occurs in breast cancer. If sentinel node is healthy, one does not need to remove several lymph nodes from the armpit (axillary space). Since axillary spasm causes a considerable risk of subsequent arthroplasty, the last few years have begun to investigate whether axillary space can be dispensed with even when there is microscopic tumor spread to the sentinel node. So far, the results are promising, but the data is still too small to be implemented on a broad front. The current study, which has been named SENOMAC, raises the question of the need for axillary evacuation in patients with breast cancer who have microscopic tumor spread to the concierge. In order to obtain a scientifically high-quality response, the study is carried out with randomization, which means that patients after their sentinel node biopsy are randomized to either undergo axillary clearance or also abstain from it. The study is ongoing at many hospitals both in Sweden and in Denmark. The goal is to show that one can limit the extent of the surgery in the armpit, and thus reduce the incidence of the arm, without impairing the prognosis. With the SENOMAC study, we want to show that axillary clearance does not need to be done in microscopic tumor proliferation of the breast cancer to the sentinel node. Indirectly, this means that it is not the surgery itself, but rather the usual additional treatments that protect against relapse. We want to make sure that surgery in the armpit is just as extensive as is needed but not unnecessarily large, and that the quality of life and the arm function are thereby improved for a large number of women every year.

Sentinel node, or the concierge, is the first lymph node in the armpit that receives lymph from the breast, and thus also the first site where tumor cells accumulate if proliferation with the lymph flow occurs in breast cancer. If sentinel node is healthy, one does not need to remove several lymph nodes from the armpit (axillary space). Since axillary spasm causes a considerable risk of subsequent arthroplasty, the last few years have begun to investigate whether axillary space can be dispensed with even when there is microscopic tumor spread to the sentinel node. So far, the results are promising, but the data is still too small to be implemented on a broad front. The current study, which has been named SENOMAC, raises the question of the need for axillary evacuation in patients with breast cancer who have microscopic tumor spread to the concierge. In order to obtain a scientifically high-quality response, the study is carried out with randomization, which means that patients after their sentinel node biopsy are randomized to either undergo axillary clearance or also abstain from it. The study is ongoing at many hospitals both in Sweden and in Denmark. The goal is to show that one can limit the extent of the surgery in the armpit, and thus reduce the incidence of the arm, without impairing the prognosis. With the SENOMAC study, we want to show that axillary clearance does not need to be done in microscopic tumor proliferation of the breast cancer to the sentinel node. Indirectly, this means that it is not the surgery itself, but rather the usual additional treatments that protect against relapse. We want to make sure that surgery in the armpit is just as extensive as is needed but not unnecessarily large, and that the quality of life and the arm function are thereby improved for a large number of women every year.