EUCTR2010-020472-34-IT
Active, not recruiting
Not Applicable
18F-Fluorothymidine Positron Emission Tomography as an early predictor of response to neoadjuvant therapy in patients with locally advanced breast carcinoma - ND
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast carcinoma classified as cT1b,c, T2, T3, or cT4 a-c, cN0-2, N3, M0
- Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
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
Outcomes
Primary Outcomes
Not specified
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