None listed
Conditions
Brief summary
This tissue collection substudy aims to store primary tissue samples at the Breast Cancer Trials (BCT) Tissue Bank in Newcastle, NSW, for use in future research projects to investigate various aspects of cancer. Who Is It For? Patients who are randomized to the ANZ 1501 POSNOC study in Australia and New Zealand. Trial Details: If you decide to take part in the main POSNOC study, you will be asked to sign and date a consent form. As part of the study, researchers will take samples of your tumour from your breast cancer surgery for use in future research. You will not need to have any additional tissue biopsies taken as a result of giving your permission to use your tissue for this purpose. All primary tumour tissue samples will be stored at the BCT Tissue Bank for use in future research projects to investigate various aspects of cancer. All future research on stored tissue will have ethics approval and will be conducted under the supervision of the BCT Scientific Advisory Committee. Research conducted on the tissue samples will not be used for commercial gain. Tissue banking is a way of securely storing samples for use in future research when new tests may become available, so we expect to keep your samples for a long time. The use of banked tissue in future research may help researchers learn more about different types of cancers and how to treat them. The diversity within cancer tissue means that the most reliable information about breast cancer is obtained from clinical trials, as these often look at very specific types of breast cancers. Therefore, they can aim to tailor treatments to the individual patient to find the best outcome for that patient. Translational research (looking at what happens in tissue/tumour cells and then translating the findings to find the most effective way to treat a patient) is best conducted when linked to the information gained from a clinical trial. Patients will not be identified by name. The only identification of tissue will be by a patient study number, hospital or clinic number, patient initials and date of birth. All testing performed on tumour tissue will be performed anonymously. Tumour tissue will be stored indefinitely.
Interventions
Primary breast tumour sample will be collected during surgery from all patients randomized to the main POSNOC study in Australia and New Zealand.
Main study: Protocol RD-5103-001-13 - A randomized controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes.
ISRCTN54765244
NCT02401685
Sponsors
Breast Cancer Trials
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed