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

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ClinicalTrials.gov Identifier: NCT01539876
Recruitment Status : Withdrawn (Disease Site Team changed research focus unlikely to have sufficient support to complete study)
First Posted : February 28, 2012
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Muriel Brackstone, Lawson Health Research Institute

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

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Fine needle aspiration assessing tumour TNFa levels Phase 1

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. measure tissue TNFa levels [ Time Frame: 18 months ]
    The TNFa levels will be evaluated using ELISA method



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Muriel Brackstone, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01539876     History of Changes
Other Study ID Numbers: TNFactor
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Muriel Brackstone, 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