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

NCT01539876 | Withdrawn Phase 1

• 1 other identifier: TNFactor
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

locally advanced breast cancer patients

Outcome Measures

Primary Outcomes (1)

• measure tissue TNFa levels

  The TNFa levels will be evaluated using ELISA method

  18 months

Study Arms (1)

Fine Needle aspiration will be done X5:

OTHER

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

Fine needle aspiration assessing tumour TNFa levels PROCEDURE

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:

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Muriel Brackstone, MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: February 28, 2012
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

CA (1)