Clinical trial · Interventional
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
NCT01539876CI-TRIAL-00014102TNFactorwithdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Disease Site Team changed research focus unlikely to have sufficient support to complete study
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fine needle aspiration assessing tumour TNFa levels | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Fine Needle aspiration will be done X5:
- 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
- interventionNames
- Procedure: Fine needle aspiration assessing tumour TNFa levels
Primary outcomes (1)
- measure
- measure tissue TNFa levels
- timeFrame
- 18 months
- description
- The TNFa levels will be evaluated using ELISA method
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.