Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neoadjuvant Docetaxel
NCT ID: NCT01539876
Last Updated: 2014-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
Brief Summary
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Detailed Description
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\- Assess whether docetaxel can induce TNFa expression in breast cancer patients being treated with docetaxel
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Fine Needle aspiration will be done X5:
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 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Muriel Brackstone
Principal Investigator
Principal Investigators
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Muriel Brackstone, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Locations
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London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada
Countries
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Other Identifiers
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TNFactor
Identifier Type: -
Identifier Source: org_study_id
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