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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    1900
  • sponsor
    University Hospitals of Derby and Burton NHS Foundation Trust
Updated on 24 January 2021
estrogen
growth factor
endocrine therapy
hormone therapy
epidermal growth factor receptor
HER2
EGFR
adjuvant therapy
erbb2
epidermal growth factor
estrogen receptor
mastectomy
immunostimulant
sentinel node
breast cancer staging
breast-conserving surgery
sentinel lymph node biopsy

Summary

POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial.

Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years.

Stratification: Institution, Age (<50, 50), Breast-conserving surgery (BCS) or mastectomy, Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2), Intra-operative sentinel assessment using OSNA (yes, no).

Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)).

Sample Size: 1900 participants

Follow-up: Participants will be followed up for 5 years.

Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant therapy alone.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment adjuvant therapy, Axillary treatment
Clinical Study IdentifierNCT02401685
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: breast carcinoma or cancer, breast or Breast Cancer Diagnosis or Breast Cancer?
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
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