Prognostic role of immune environment in luminal B early breast cancer

Not Applicable

Completed

• Conditions: Luminal B Early Breast Cancer; Cancer - Breast; uminal B Early Breast Cancer

• Registration Number: ACTRN12622000787785
• Lead Sponsor: Breast Cancer Research Centre - WA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-05-11
• Study Start: 2022-06-02
• Last Update Posted: 6 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients with Stage I, II and III breast cancer managed by the Principal Investigator between January 2000 to June 2013
Luminal B disease
Patient aged between 45 - 55 years of age at time of diagnosis
Adequate tissue from primary breast tissue and axillary node for evaluation
Follow-up for minimum of 12 months from diagnosis

Exclusion Criteria

Patient lost to follow-up prior to 12 months
Patient non-compliant with recommended local or systemic adjuvant therapy
Luminal A breast cancer as defined as any histological type invasive carcinoma which is grade 1 and HER2 negative
Contralateral breast cancer in the absence of loco-regional relapse and/or metastatic relapse will not be regarded as a breast cancer event
.Comorbidities which may be associated with altered immune function: rheumatoid arthritis, autoimmune illness, HIV-associated illness.
Other malignancies with the exception of non-melanomatous skin cancer, which were managed by surgical excision or topical cryotherapy in the past
Previous exposure to cytotoxic or immunotherapy.
Previous radiation therapy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any difference in the numbers of any immune cell type between relapsed versus non-relapsed cases as identified via reverse transcriptase-polymerase chain reaction (RT-PCR) and immunohistochemical evaluation of primary tissue[Completion of pathological review of all samples by April 2022];Any difference in the numbers of any immune cell type between relapsed versus non-relapsed cases as identified via reverse transcriptase-polymerase chain reaction (RT-PCR) and immunohistochemical evaluation of nodal axillary tissue[At end of pathological review of all tissue samples by April 2022]

Secondary Outcome Measures

Name	Time	Method
Feasibility of screening archived breast and nodal specimens by reverse transcriptase-polymerase chain reaction(RT-PCR) for proposed molecular markers as shown by completion of histopathological evaluation as documented in study records<br>Examples of molecular markers of suppressor and effector immune cells subsets include<br>Cytotoxic CD8+T lymphocytes (CTLs)CD8+, Perforin+, IFN?+<br>M1macrophages CD11b+,CD68+, HLA-DR+, CD40+, IL-12+, TNFa+<br>Activated dendritic cells CD11c+, HLA-DR+,CD40+, IL-12+, TNFa+, IFN?+[Completion of histopathological review of all samples by April 2022]