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

March 24, 2014 updated by: Muriel Brackstone, Lawson Health Research Institute

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / 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

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program of the Lawson Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fine Needle aspiration will be done X5:
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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Muriel Brackstone, MD, Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 28, 2012

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNFactor

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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