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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01539876

Acronym

TNFactor

Enrollment

Registered

2012-02-28

Start date

Unknown

Completion date

Unknown

Last updated

2014-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

locally advanced breast cancer patients

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

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
measure tissue TNFa levels	18 months	The TNFa levels will be evaluated using ELISA method

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026