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

Lawson Health Research Institute

Status and phase: Withdrawn; Phase 1

Conditions: Breast Cancer

Treatments: Procedure: Fine needle aspiration assessing tumour TNFa levels

Study type: Interventional

Funder types: Other

Identifiers

NCT01539876

TNFactor

Details and patient eligibility

About

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

Full 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

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Fine Needle aspiration will be done X5:

Other group

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

Treatment:

Procedure: Fine needle aspiration assessing tumour TNFa levels