Trial Coordinator - Lucy Matthews
Data Manager - Shirley May
Funder: NIHR HTA
Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Women diagnosed with breast cancer undergo investigations to determine which treatments will be best for them. Treatment is usually surgery followed by 'adjuvant therapy' (one or more of the following: radiotherapy to the chest wall, chemotherapy, hormone therapy).
During breast surgery, one or two lymph nodes in the armpit (axilla) are examined. This is called a sentinel node biopsy. If these sentinel nodes contain cancer deposits, NICE Guidance states that the remaining lymph nodes in the armpit should be removed by surgery (axillary clearance), or irradiated (axillary radiotherapy). Both of these treatments can have life-long effects on arm and shoulder movement and can also cause pain and swelling of the arm (lymphoedema).
Experts question whether these treatments are really necessary in patients who have just one or two lymph nodes containing cancer. Adjuvant therapy alone may be sufficient. This is the aim of POSNOC. Women, whose sentinel node biopsy shows that only one or two lymph nodes contained cancer, are eligible to take part in POSNOC. Participants will be randomised in equal numbers between two treatment arms.
SHORE-C have produced a patient friendly DVD, to complement the patient information leaflet, which explains the study using graphics and simple language, to help women decide whether or not they would like to take part.
QoL assessment is a very important part of this study because patients receiving axillary treatment may suffer long term side-effects that can affect daily living. However women who do not receive axillary clearance or radiotherapy to the axilla may be more worried about their cancer returning. We will measure QoL using the FACT B+4 questionnaire, which has been specifically designed for patients following surgery for breast cancer, and daily living using the EQ-5D questionnaire. The Spielberger State/Trait Anxiety Inventory explores aspects of anxiety according to personality (trait) and as triggered by events (state). POSNOC participants will be asked to complete these questionnaires before randomisation and then 3, 6, 12, 24 and 36 months later.
In April 2024 the study team secured additional funding to collect quality of life data at 5 years. These postal questionnaires will be sent to participants at 5 years after they joined the study. The patients' responses will provide valuable insight into how modern breast cancer treatments impact on patients' everyday lives and help researchers gain a better understanding of the long-term outcomes of breast cancer treatment.
Number of patients recruited: 1692
Current Stage:
In follow-up
Publication
POSNOC - Positive Sentinel Node: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomised controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel http://www.thelancet.com/protocol-reviews/14PRT-0519Publication
POSNOC - POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy _ Procotol paper https://bmjopen.bmj.com/content/11/12/e054365Poster
Measuring patient reported outcomes in the POSNOC trial: Strategies employed to promote high quality data return posters/POSNOC PRO final for ICTMC Oct 2019.pdf Presented at International Clinical Trials Methodology Conference (ICTMC) 2019Patient Information Film
POSNOC Patient Information Film https://youtu.be/4kAtvXV7kPM