A trial to test two radioactive tracers compared to standard imaging (MRI) when assessing how effective treatment for Breast cancer has been.

A randomised phase II trial of [18F]fluorothymidine and the standard tracer [18F]Fluorodeoxyglucose in the assessment of systemic therapy response in triple negative breast cancer and their utility compared to conventional MRI imaging response, early ADC change and biopsy derived biomarkers - TNBC:Novel functional imaging to determine early chemotherapy response

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004220-34-GB

Enrollment

Registered

2011-12-05

Start date

2012-01-19

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple Negative Breast Cancer MedDRA version: 17.0 Level: LLT Classification code 10006192 Term: Breast cancer NOS System Organ Class: 100000004864

Interventions

Product Name: [18F]Fluorothymidine Pharmaceutical Form: Solution for injection INN or Proposed INN: 3'-deoxy-3'-[18F]fluorothymidine Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Female age 18 to 70 years • Women of childbearing potential must have documented negative pregnancy test within the 2 weeks prior to day 1 chemotherapy and agree to use a medically acceptable birth control during the duration of their chemotherapy. • Stage II-III biopsy proven early breast cancer for which primary chemotherapy is recommended. Staging performed in accordance with local protocols. • All patients will have HER2 negative primary tumours (IHC 0 or 1+, or IHC 2+ and FISH non-amplified (ratio of Her2 to chromosome 17 of more than 2.0) • All patients will have ER negative primary invasive breast cancer (Allred 2cm • Eligible for neoadjuvant chemotherapy according to departmental protocols • Written informed consent • Able to comply with treatment plans, scheduled visits, all study PET imaging and biopsy procedures and follow-up Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: • Any prior treatment for the breast cancer • Patients who are pregnant will be excluded. • Patients who are breast feeding • Evidence of metastasic disease at diagnosis precluding neoadjuvant chemotherapy. • Requirement for concurrent radiotherapy treatment • Serious medical condition or concurrent medical illness likely to compromise ability to complete prescribed chemotherapy course. • Anticoagulation requirement which would preclude serial biopsy • Diabetes Mellitus • Any other problems that may make the patient unable to tolerate the PET scans or translational biopsies • Investigational Medicinal Product in the previous 28 days

Design outcomes

Primary

Measure	Time frame
Main Objective: Part A: To confirm repeatability of Positron Emission Tomography (PET) scan SUV measurement before chemotherapy in triple negative breast cancer using [18F]FLT and [18F]FDG tracers Parts A and B: To evaluate PET imaging using [18F]FLT or [18F]FDG as a method for evaluating response to systemic therapy in primary triple negative breast cancer ; Secondary Objective: 1. optimal scan time post FDG and FLT tracer injection 2. correlate PET imaging response in breast and axillary nodes with residual cancer burden at definitive surgery 3. correlate PET functional imaging changes (SUV response) with changes in biopsy derived markers of proliferation and apoptosis changes 4.assessment of Ki and K1 for each tracer 5. To assess nodal response using PET imaging 6. confirm the safety of FLT 7. To obtain performance estimates for the ability of the Part B tracer (FDG or FLT) response derived from integration of Apparent Diffusion Coefficient (ADC) and size change data at 3 cycles 8. To obtain exploratory performance estimates for ADC change after 1 cycle to report RECIST response after 3 cycles 9. To correlate ADC change with biopsy derived proliferation and apoptosis biomarkers ; Primary end point(s): Part A Repeatability for both tracers will be within 20% (second scan at 3 days after first PET +/- 10% of baseline) Part B Correlation of SUV response for each tracer with conventional MRI RECIST response assessment after 3 cycles neoadjuvant chemotherapy ; Timepoint(s) of evaluation of this end point: Part A second scan at 3 days Part B after 3 cycles neoadjuvant chemotherapy	—

Measure

Time frame

Main Objective: Part A: To confirm repeatability of Positron Emission Tomography (PET) scan SUV measurement before chemotherapy in triple negative breast cancer using [18F]FLT and [18F]FDG tracers Parts A and B: To evaluate PET imaging using [18F]FLT or [18F]FDG as a method for evaluating response to systemic therapy in primary triple negative breast cancer ; Secondary Objective: 1. optimal scan time post FDG and FLT tracer injection 2. correlate PET imaging response in breast and axillary nodes with residual cancer burden at definitive surgery 3. correlate PET functional imaging changes (SUV response) with changes in biopsy derived markers of proliferation and apoptosis changes 4.assessment of Ki and K1 for each tracer 5. To assess nodal response using PET imaging 6. confirm the safety of FLT 7. To obtain performance estimates for the ability of the Part B tracer (FDG or FLT) response derived from integration of Apparent Diffusion Coefficient (ADC) and size change data at 3 cycles 8. To obtain exploratory performance estimates for ADC change after 1 cycle to report RECIST response after 3 cycles 9. To correlate ADC change with biopsy derived proliferation and apoptosis biomarkers ; Primary end point(s): Part A Repeatability for both tracers will be within 20% (second scan at 3 days after first PET +/- 10% of baseline) Part B Correlation of SUV response for each tracer with conventional MRI RECIST response assessment after 3 cycles neoadjuvant chemotherapy ; Timepoint(s) of evaluation of this end point: Part A second scan at 3 days Part B after 3 cycles neoadjuvant chemotherapy

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Secondary

Measure	Time frame
Secondary end point(s): The Time point in triple negative breast cancer where tumour SUV peaks Residual cancer burden in breast and axilla Correlation with percentage cells positive for proliferation markers Ki-67 (MIB1), geminin, mcms and tunel apoptosis assay, tumour genotype and mRNA expression markers of proliferation genes in residual tumour (if present). The dynamic analysis will use an input function derived from the aorta or the heart or both to derive rate constants Ki and k1, measurements of transport of and phosphorylation for both tracers Correlate SUV response in the nodes with SUV response in the breast primary Evaluate the ability of FDG and FLT tracers to predict subsequent MRI response as a function of integrated ADC and size change Evaluate the ability of early ADC change to predict subsequent MRI response Correlation with % cells +ve for proliferation markers Ki-67 (MIB1), geminin, mcms and tunel apoptosis assay, tumour genotype and mRNA expression markers of proliferation genes in residual tumour (if present). Determining the causality of each adverse event to the [18F]FLT tracer, and grade AE severity according to NCI CTCAE version 4.0.	—

Measure

Time frame

Secondary end point(s): The Time point in triple negative breast cancer where tumour SUV peaks Residual cancer burden in breast and axilla Correlation with percentage cells positive for proliferation markers Ki-67 (MIB1), geminin, mcms and tunel apoptosis assay, tumour genotype and mRNA expression markers of proliferation genes in residual tumour (if present). The dynamic analysis will use an input function derived from the aorta or the heart or both to derive rate constants Ki and k1, measurements of transport of and phosphorylation for both tracers Correlate SUV response in the nodes with SUV response in the breast primary Evaluate the ability of FDG and FLT tracers to predict subsequent MRI response as a function of integrated ADC and size change Evaluate the ability of early ADC change to predict subsequent MRI response Correlation with % cells +ve for proliferation markers Ki-67 (MIB1), geminin, mcms and tunel apoptosis assay, tumour genotype and mRNA expression markers of proliferation genes in residual tumour (if present). Determining the causality of each adverse event to the [18F]FLT tracer, and grade AE severity according to NCI CTCAE version 4.0.

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Countries

United Kingdom

Contacts

Public ContactPET Imaging Centre

PET Imaging Centre

+4402071884988

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026