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

Breast Cancer Clinical Trial

— TNFactor  

Official title:

Assessing Serial Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neo-adjuvant Taxane Chemotherapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01539876
• Other study ID #: TNFactor
• Status: Withdrawn
• Phase: Phase 1
• First received: February 22, 2012
• Last updated: March 24, 2014

Study information

• Verified date: March 2014
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	London Regional Cancer Program of the Lawson Health Research Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure tissue TNFa levels	The TNFa levels will be evaluated using ELISA method	18 months	No