Breast carcinoma classified as cT1b,c, T2, T3, or cT4 a-c, cN0-2, N3, M0 MedDRA version: 9.1 Level: HLT Classification code 10006289
Conditions
Interventions
Product Name: 3-DE18F-FLT (3`-deoxy-3`-[18F]fluorothymidine)
Pharmaceutical Form: Solution for injection
Other descriptive name: 18F-FLT (3`-deoxy-3`-[18F]fluorothymidine)
Concentration unit: MBq/ml
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Premenopausal or postmenopausal patients with histologically proven primary breast cancer aged =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with distant metastases. • Patients with previous or concomitant malignancy except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, or contra- or ipsilateral in situ breast carcinoma. • Patients who have received prior therapy for breast cancer including prior irradiation, neoadjuvant chemotherapy or other preventative therapies. • Patients with non-malignant systemic diseases that would prevent them from undergoing any of the treatment options, or would prevent prolonged follow-up. • Patients who either have been pregnant or who have lactated within 6 months of diagnosis. • Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this study we will investigate the hypothesis that a reduction of 18F-FLT uptake in the tumor after the first cycle of neoadjuvant chemotherapy, compared to the baseline, may predict the response to the treatment.;Secondary Objective: - To compare proliferation index (Ki 67) with the uptake value of 18F-FLT. - To compare the changes in 18F-FLT uptake with those detected by pathologist in the tru-cut sample obtained after the first course of treatment (when performed). - To compare 18F-FLT uptake and 18-FDG uptake at the baseline.;Primary end point(s): The primary aim of the study is to determine the association between tumor FLT uptake reduction after 3 weeks of treatment and the response to primary therapy, expressed in terms of pathological Complete Response (pCR) and partial response (PR) | — |
Countries
Italy
Outcome results
None listed