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

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点开始时间: 2010年12月24日最近更新: 2012年3月19日

适应症

试验速览

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•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

•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

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