Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neoadjuvant Docetaxel
Phase 1
Withdrawn
- Conditions
- Breast Cancer
- Interventions
- Procedure: Fine needle aspiration assessing tumour TNFa levels
- Registration Number
- NCT01539876
- Lead Sponsor
- Lawson Health Research Institute
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fine Needle aspiration will be done X5: 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
- Primary Outcome Measures
Name Time Method measure tissue TNFa levels 18 months The TNFa levels will be evaluated using ELISA method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
London Regional Cancer Program of the Lawson Health Research Institute
🇨🇦London, Ontario, Canada