POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer

Launched by UNIVERSITY HOSPITALS OF DERBY AND BURTON NHS FOUNDATION TRUST · Mar 27, 2015

Keywords

ClinConnect Summary

The POSNOC trial is researching the best treatment approach for women with early-stage breast cancer who have one or two affected lymph nodes. Specifically, it aims to determine whether receiving additional treatment for the lymph nodes (like surgery or radiation) is necessary or if standard therapy alone is just as effective in preventing cancer from returning in that area over the next five years. This study involves about 1,900 women and will assess different factors, such as age and type of surgery, to see how they affect treatment outcomes.

To participate in the trial, women should have a specific type of breast tumor that's 5 cm or smaller and have been diagnosed with one or two lymph nodes containing cancer cells. Eligible participants will receive standard cancer treatments, which may include chemotherapy and hormone therapy, and will be monitored for five years. It's important to note that those who have had certain prior treatments or surgeries may not qualify. Overall, this trial aims to provide valuable insights into breast cancer treatment options while ensuring that participants receive appropriate care throughout the study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Unifocal or multi-focal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or largest invasive tumour diameter on radiology should be used for women who are randomised intra-operatively or undergo sentinel node biopsy before neoadjuvant therapy (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci)
• • At sentinel node biopsy have 1 or 2 nodes with macrometastases (tumour deposit \>2.0mm in largest dimension or defined as macrometastasis on molecular assay)
• • Fit for axillary treatment and adjuvant therapy
• • Have given written informed consent
• Exclusion Criteria:
• • bilateral invasive breast cancer
• • more than 2 nodes with macrometastases
• * neoadjuvant therapy for breast cancer except:
• • if sentinel node biopsy performed prior to neoadjuvant chemotherapy in women with early breast cancer
• • short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months)
• • previous axillary surgery on the same body side as the scheduled sentinel node biopsy
• • not receiving adjuvant systemic therapy
• * previous cancer less than 5 years previously or concomitant malignancy except:
• • basal or squamous cell carcinoma of the skin
• • in situ carcinoma of the cervix
• • in situ melanoma
• • contra- or ipsilateral in situ breast cancer

Trial Officials