EUCTR2011-004220-34-GB
Active, Not Recruiting
Phase 1
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
ConditionsTriple Negative Breast CancerMedDRA version: 17.0 Level: LLT Classification code 10006192 Term: Breast cancer NOS System Organ Class: 100000004864Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
DrugsMetaTrace FDG
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Triple Negative Breast Cancer
- Sponsor
- King's College London
- Enrollment
- 22
- Status
- Active, Not Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<3\)
- •ECOG PS of 0 or 1
- •Primary tumour size \>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
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
Outcomes
Primary Outcomes
Not specified
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