Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neoadjuvant Docetaxel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the fine needle aspiration methodology in collecting sufficient tumour cells to measure tissue TNFa levels serially in human breast cancer sample receiving Taxane treatment

Detailed Description
-----------------
This pilot study will begin to test the clinical relevance of the TNFa pathway in docetaxel response in breast cancer patients receiving Taxane chemotherapy. - Assess whether docetaxel can induce TNFa expression in breast cancer patients being treated with docetaxel

Official Title
-----------------
Assessing Serial Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neo-adjuvant Taxane Chemotherapy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Fine needle aspiration assessing tumour TNFa levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven LABC, Locally advanced breast cancer. (operable or non-operable) Any T3/T4 or N2, N3 Clinical TNM stage breast cancer without metastases ECOG Performance Status of 0, 1 or 2. Patients should be able to comprehend the Letter of Information and be capable of giving informed consent. Female age 18 years old History and physical Negative serum pregnancy test for women of child bearing age Exclusion Criteria: Inflammatory cancer (as defined by clinical evidence of dermal-lymphatic tumour involvement.) Ineligible for chemotherapy Patients with metastatic disease. Patients who have received prior chemotherapy or radiotherapy for this or any other malignancy. Previous breast cancer diagnosis Pregnant or lactating females are ineligible. Female patients of reproductive potential who decline to employ an adequate contraceptive method are ineligible. Participation in any concomitant trials.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fine Needle aspiration will be done X5:<br>Fine Needle aspiration will be done X5: 1 hr pre-treatment, 1hr post treatment,24 hrs post treatment, 48 hrs post treatment, and following last chemotherapy cycle | Procedure: Fine needle aspiration assessing tumour TNFa levels<br>* Fine Needle aspiration will be done X5: 1 hr pre-treatment, 1hr post treatment,24 hrs post treatment, 48 hrs post treatment, and following last chemotherapy cycle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure tissue TNFa levels | The TNFa levels will be evaluated using ELISA method | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
locally advanced breast cancer patients