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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

February 22, 2012
April 19, 2013
April 2013
September 2013   (final data collection date for primary outcome measure)
measure tissue TNFa levels [ Time Frame: 18 months ] [ Designated as safety issue: No ]
The TNFa levels will be evaluated using ELISA method
Same as current
Complete list of historical versions of study NCT01539876 on ClinicalTrials.gov Archive Site
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Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neoadjuvant Docetaxel
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

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
Interventional
Phase 1
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Breast Cancer
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
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
Intervention: Procedure: Fine needle aspiration assessing tumour TNFa levels
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Not Provided
Canada
 
NCT01539876
TNFactor
No
Muriel Brackstone, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Muriel Brackstone, MD Lawson Health Research Institute
Lawson Health Research Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP