18F-Fluorothymidine Positron Emission Tomography as an early predictor of response to neoadjuvant therapy in patients with locally advanced breast carcinoma - ND

Conditions: Breast carcinoma classified as cT1b,c, T2, T3, or cT4 a-c, cN0-2, N3, M0
MedDRA version: 9.1Level: HLTClassification code 10006289

Registration Number: EUCTR2010-020472-34-IT

Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

•Premenopausal or postmenopausal patients with histologically proven primary breast cancer aged < 75 years
•Tumor classified as cT1b,c, T2, T3, or cT4 a-c, cN0-2, N3, M0
• Patients must have had a TRU-CUT biopsy.
•c-erbB-2 expression must be known by immunohistochemistry
•Patients must be suitable for preoperative therapy according to EIO guidelines or protocols
•Patients must be informed of, and agree to, data and material transfer and handling, in accordance with national data protection guidelines
•Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
•Patients must be accessible for 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- 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).<br>- 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)

Secondary Outcome Measures