NL-OMON21498
Recruiting
Not Applicable
Tumorresponse monitoring in patients with breast cancer treated with primary systemic therapy: Towards predicting response in both the primary tumor and in axillary lymph nodes.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- breast cancerneoadjuvant chemotherapyaxillary lymph node metastasisFDG-PET/CTIodine-125 seeds
- Sponsor
- Philips
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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