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WithdrawnNCT01539876TNFactorUpdated Mar 26, 2014

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

A Phase 1 interventional study of Fine needle aspiration assessing tumour TNFa levels in Breast Cancer, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Withdrawn at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Phase 1, Interventional, and Basic science

Why this study was withdrawn
Disease Site Team changed research focus unlikely to have sufficient support to complete study
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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

Read the 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
02

Conditions studied

  • Breast Cancer

Keywords

  • locally advanced breast cancer patients
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureFine 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

06

What researchers measure

Primary outcomes

  1. measure tissue TNFa levels

    The TNFa levels will be evaluated using ELISA method

    Time frame: 18 months

07

Study locations

1 site
  • London Regional Cancer Program of the Lawson Health Research Institute
    London, Ontario N6A 4L6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01539876
Lead sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Responsible party
Muriel Brackstone (Principal Investigator, London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Feb 28, 2012
Last update
Mar 26, 2014

Study contacts

Muriel Brackstone, MD
principal investigator · London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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