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


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

measure tissue TNFa levels

Outcome Description:

The TNFa levels will be evaluated using ELISA method

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Muriel Brackstone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lawson Health Research Institute

Authority:

Canada: Ethics Review Committee

Study ID:

TNFactor

NCT ID:

NCT01539876

Start Date:

April 2013

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • locally advanced breast cancer patients
  • Breast Neoplasms
  • Necrosis

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