Onderzoek naar het bepalen van de reactie op chemotherapie van tumorcellen in de borst en in de oksel.
- Conditions
- breast cancerneoadjuvant chemotherapyaxillary lymph node metastasisFDG-PET/CTIodine-125 seeds
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
1. Proven infiltrating breast cancer with either a primary tumor over 3 cm in size (clinical examination) or cytologically proven spread to the axillary lymph nodes;
2. Stage II or stage III disease (revised AJCC staging system 2001). 'Locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. In stage II patients with T1N1 disease, N1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of over 2 mm in diameter at sentinel node biopsy. Stage IIA patients are only eligible if the tumor is over 3 cms in diameter;
1. Evidence of distant metastases. Staging examinations must have included a chest roentgenogram, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if bone metastases were excluded by MRI;
2.Previous radiation therapy or chemotherapy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of FDG PET and MRI to predict a favourable tumour response of the primary tumor defined as (near) pathological complete remission<br>Sensitivity and specificity of FDG PET/CT and radioactive I-125 seed localisation to predict a favourable tumour response of the axilla, defined as pathological complete remission or residual micrometastasis.
- Secondary Outcome Measures
Name Time Method Fusion of PET images with MRI images to achieve better anatomical localisation and to compare tumour response evaluation.