scholarly journals Evaluation of axillary reverse mapping (ARM) in clinically axillary node negative breast cancer patients - Randomised controlled trial

2020 ◽  
Vol 75 ◽  
pp. 174-178 ◽  
Author(s):  
Mohamed I. Abdelhamid ◽  
Amr Abdel Bari ◽  
Mohamed I. Farid ◽  
Hazem Nour
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Axillary Node ◽  
Breast Cancer Patients ◽  
Node Negative ◽  
Axillary Reverse Mapping ◽  
Node Negative Breast Cancer ◽  
Randomised Controlled ◽  
Reverse Mapping

scholarly journals Tumor-Biological Factors Upa and PAI-1 as Stratification Criteria of a Multicenter Adjuvant Chemotherapy Trial in Node-Negative Breast Cancer

2000 ◽  
Vol 15 (1) ◽  
pp. 73-78 ◽  
Author(s):  
A. Prechtl ◽  
N. Harbeck ◽  
C. Thomssen ◽  
C. Meisner ◽  
M. Braun ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Plasminogen Activator ◽  
Systemic Therapy ◽  
Axillary Node ◽  
Breast Cancer Patients ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
Pai 1

In axillary node-negative primary breast cancer, 70% of the patients will be cured by locoregional treatment alone. Therefore, adjuvant systemic therapy is only needed for those 30% of node-negative patients who will relapse after primary therapy and eventually die of metastases. Traditional histomorphological and clinical factors do not provide sufficient information to allow accurate risk group assessment in order to identify node-negative patients who might benefit from adjuvant systemic therapy. In the last decade various groups have reported a strong and statistically independent prognostic impact of the serine protease uPA (urokinase-type plasminogen activator) and its inhibitor PAI-1 (plasminogen activator inhibitor type 1) in node-negative breast cancer patients. Based on these data, a prospective multicenter therapy trial in node-negative breast cancer patients was started in Germany in June 1993, supported by the German Research Association (DFG). Axillary node-negative breast cancer patients with high levels of either or both proteolytic factors in the tumor tissue were randomized to adjuvant CMF chemotherapy versus observation only. Recruitment was continued until the end of 1998, by which time 684 patients had been enrolled. Since then, patients have been followed up in order to assess the value of uPA and PAI-1 determination as an adequate selection criterion for adjuvant chemotherapy in node-negative breast cancer patients. This paper reports on the rationale and design of this prospective multicenter clinical trial, which may have an impact on future policies in prognosis-oriented treatment strategies.

scholarly journals INvolvement of breast CAncer patients during oncological consultations: a multicentre randomised controlled trial—the INCA study protocol

BMJ Open ◽  
2013 ◽  
Vol 3 (5) ◽  
pp. e002266 ◽  
Author(s):  
Claudia Goss ◽  
Alberto Ghilardi ◽  
Giuseppe Deledda ◽  
Chiara Buizza ◽  
Alessandro Bottacini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Cancer Patients ◽  
Study Protocol ◽  
Controlled Trial ◽  
Breast Cancer Patients ◽  
Randomised Controlled

How To Use Prognostic Factors in Axillary Node-Negative Breast Cancer Patients

1990 ◽  
Vol 82 (12) ◽  
pp. 1006-1015 ◽  
Author(s):  
William L. McGuire ◽  
Atul K. Tandon ◽  
D. Craig Allred ◽  
Gary C. Chamness ◽  
Gary M. Clark
Keyword(s):  
Breast Cancer ◽  
Prognostic Factors ◽  
Cancer Patients ◽  
Axillary Node ◽  
Breast Cancer Patients ◽  
Node Negative ◽  
Node Negative Breast Cancer

scholarly journals PRO B: evaluating the effect of an alarm-based patient-reported outcome monitoring compared with usual care in metastatic breast cancer patients—study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Maria Margarete Karsten ◽  
Friedrich Kühn ◽  
Therese Pross ◽  
Jens-Uwe Blohmer ◽  
Anna Maria Hage ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Intervention Group ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Outcome Monitoring ◽  
Patient Reported ◽  
Randomised Controlled

Abstract Background Despite the progress of research and treatment for breast cancer, still up to 30% of the patients afflicted will develop distant disease. Elongation of survival and maintaining the quality of life (QoL) become pivotal issues guiding the treatment decisions. One possible approach to optimise survival and QoL is the use of patient-reported outcomes (PROs) to timely identify acute disease-related burden. We present the protocol of a trial that investigates the effect of real-time PRO data captured with electronic mobile devices on QoL in female breast cancer patients with metastatic disease. Methods This study is a randomised, controlled trial with 1:1 randomisation between two arms. A total of 1000 patients will be recruited in 40 selected breast cancer centres. Patients in the intervention arm receive a weekly request via an app to complete the PRO survey. Symptoms will be assessed by study-specific optimised short forms based on the EORTC QLQ-C30 domains using items from the EORTC CAT item banks. In case of deteriorating PRO scores, an alarm is sent to the treating study centre as well as to the PRO B study office. Following the alarm, the treating breast cancer centre is required to contact the patient to inquire about the reported symptoms and to intervene, if necessary. The intervention is not specified and depends on the clinical need determined by the treating physician. Patients in the control arm are prompted by the app every 3 months to participate in the PRO survey, but their response will not trigger an alarm. The primary outcome is the fatigue level 6 months after enrolment. Secondary endpoints include among others hospitalisations, use of rescue services and overall QoL. Discussion Within the PRO B intervention group, we expect lower fatigue levels 6 months after intervention start, higher levels of QoL, less unplanned hospitalisations and less emergency room visits compared to controls. In case of positive results, our approach would allow a fast and easy transfer into clinical practice due to the use of the already nationwide existing IT infrastructure of the German Cancer Society and the independent certification institute OnkoZert. Trial registration DRKS (German Clinical Trials Register) DRKS00024015. Registered on 15 February 2021

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