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

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Breast Cancer

Interventions

Fine needle aspiration assessing tumour TNFa levelsPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, Canada

Outcomes

Primary Outcomes

measure tissue TNFa levels

The TNFa levels will be evaluated using ELISA method

Time frame: 18 months

Data from ClinicalTrials.gov

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