Tissue Collection Substudy in Australia and New Zealand for the participants of ANZ 1501 POSNOC (POsitive Sentinel NOde Clearance) study.

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12615000871549
• Lead Sponsor: Breast Cancer Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-21
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 208

Inclusion Criteria

Tumour samples will be collected from patients participating in the Main POSNOC study in Australia and New Zealand. Key Inclusion Criteria for POSNOC are as follows:

* 18 years or older
* Unifocal or multi-focal invasive tumour with lesion <=5 cm in its largest dimension, measured pathologically or for women who are randomised intra-operatively largest tumour diameter on mammogram or ultrasound (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 sentinel 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

Tumour samples will be collected from patients participating in the Main POSNOC study in Australia and New Zealand. Key Exclusion Criteria for POSNOC are as follows:

* bilateral breast cancer
* more than 2 nodes with macrometastases
* neoadjuvant therapy for breast cancer
* 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: adequately treated basal or squamous cell carcinoma of the skin; adequately treated in situ carcinoma of the cervix; adequately treated in situ melanoma; contra- or ipsilateral in situ breast cancer.

Study & Design

• Study Type: Observational
• Study Design: Not specified