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

Phase 1

• Conditions: Triple Negative Breast Cancer; MedDRA version: 17.0 Level: LLT Classification code 10006192 Term: Breast cancer NOS System Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2011-004220-34-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-05
• Study Completion: 2017-08-23
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 22

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

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified