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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Fine needle aspiration assessing tumour TNFa levels
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring locally advanced breast cancer patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • London Regional Cancer Program of the Lawson Health Research Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fine Needle aspiration will be done X5:

Arm Description

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

Outcomes

Primary Outcome Measures

measure tissue TNFa levels
The TNFa levels will be evaluated using ELISA method

Secondary Outcome Measures

Full Information

First Posted
February 22, 2012
Last Updated
March 24, 2014
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01539876
Brief Title
Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neoadjuvant Docetaxel
Acronym
TNFactor
Official Title
Assessing Serial Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neo-adjuvant Taxane Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Disease Site Team changed research focus unlikely to have sufficient support to complete study
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
locally advanced breast cancer patients

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fine Needle aspiration will be done X5:
Arm Type
Other
Arm Description
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 Type
Procedure
Intervention Name(s)
Fine needle aspiration assessing tumour TNFa levels
Intervention Description
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 Measure Information:
Title
measure tissue TNFa levels
Description
The TNFa levels will be evaluated using ELISA method
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muriel Brackstone, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Regional Cancer Program of the Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

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

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