Second biopsy of axillary sentinel node in the local recurrence of breast cancer after mastectomy and first negative sentinel node. Studio LiSeR - M - ND

• Conditions: patients with first local recurrence of breast cancer; MedDRA version: 12.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2009-014823-22-IT
• Lead Sponsor: AZIENDA USL DI FORLI`

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-15
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

clinical diagnosis and / or instrumental first episode of local recurrence of breast cancer parietal (B5, C4, C5, surgical biopsy), surgically removed with negative axillary objectivity and, in cases of doubt or with lymph nodes> 2cm, with ultrasound examination and possible agoaspirato negative;
staging tests negative (rx thorax and / or tac chest, eco liver and / or tac abdomen, bone scintigraphy) performed over the last 6 months;
previously undergone a mastectomy (at least 1 year) for breast carcinoma in situ or invasive histologically confirmed and resection margins free of neoplasia;
previously undergone a biopsy of the LS were negative for the primary tumor is permissible, and should be reported in the data collection, the presence of isolated tumor cells (diameter <200 microns);
whether or not previously submitted to adjuvant chemotherapy completed at least 1 month;
whether or not previously subjected to intra or postoperative radiotherapy;
being treated or not with Ormonoterapia or biological therapies;
age ≥ 18 years, female;
written informed consent.
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

axillary lymph nodes clinically and instrumentally or cyto-histologically positive;
presence of distant metastases from breast cancer;
concomitant or previous malignancies other than the subject of the Study, except for cancers for which the patient is disease-free for at least 5 years;
concomitant or previous malignancy in the contralateral breast;
non-epithelial breast malignancies (sarcoma, lymphoma etc).
psychiatric illness or other nature which preclude provide informed consent to treatment;
are pregnant resolved;
breastfeeding;
known contraindications to the technique of LS.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified