Breast CancerPhase 1TNFactorNCT01539876
Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neoadjuvant Docetaxel
A Phase 1 study testing Fine needle aspiration assessing tumour TNFa levels in people with Breast Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fine needle aspiration assessing tumour TNFa levels
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, N6A 4L6
About this study
Official title: Assessing Serial Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neo-adjuvant Taxane Chemotherapy
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
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Fine needle aspiration assessing tumour TNFa levels
- Keywords
- locally advanced breast cancer patients
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine needle aspiration assessing tumour TNFa levelsProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Fine Needle aspiration will be done X5: | Other | 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 Receives: Procedure: Fine needle aspiration assessing tumour TNFa levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure tissue TNFa levels
The TNFa levels will be evaluated using ELISA method
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
Why it stopped: Disease Site Team changed research focus unlikely to have sufficient support to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muriel Brackstone, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Muriel Brackstone, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539876
- Sponsor's protocol ID
- TNFactor
- Acronym
- TNFactor
- Status last verified
- Mar 2014
- First submitted
- 22 Feb 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Serial Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neo-adjuvant Taxane Chemotherapy
- ClinicalTrials.gov ID
- NCT01539876
- Acronym / sponsor ID
- TNFactor / TNFactor
- Conditions
- Breast Cancer
- Keywords
- locally advanced breast cancer patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Disease Site Team changed research focus unlikely to have sufficient support to complete study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fine Needle aspiration will be done X5: | Other | Procedure: Fine needle aspiration assessing tumour TNFa levelsFine 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fine needle aspiration assessing tumour TNFa levelsFine 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 | Procedure or surgery | Fine Needle aspiration will be done X5: |
Primary outcome
measure tissue TNFa levels
Time frame: 18 months
The TNFa levels will be evaluated using ELISA method
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muriel Brackstone, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fine needle aspiration assessing tumour TNFa levels in people with Breast Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure tissue TNFa levels (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.