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

This study is not yet open for participant recruitment.
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Muriel Brackstone, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01539876
First received: February 22, 2012
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Procedure: Fine needle aspiration assessing tumour TNFa levels
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Assessing Serial Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neo-adjuvant Taxane Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • measure tissue TNFa levels [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The TNFa levels will be evaluated using ELISA method


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539876

Locations
Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Muriel Brackstone, MD Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Muriel Brackstone, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01539876     History of Changes
Other Study ID Numbers: TNFactor
Study First Received: February 22, 2012
Last Updated: April 19, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
locally advanced breast cancer patients

Additional relevant MeSH terms:
Breast Neoplasms
Necrosis
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013