Status:
COMPLETED
Impact of a Surgical Sealing Patch on Lymphatic Drainage After ALND for Breast Cancer
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Axillary lymph node dissection remains an integral part of surgical treatment of primarily node-positive invasive breast cancer. In order to reduce the incidence of clinically relevant seroma, a sucti...
Detailed Description
DISEASE BACKGROUND In Switzerland, 5'500 women and 30 to 40 men are diagnosed with breast cancer every year. It accounts for one third of all cancer diagnoses among women, and causes approximately 1'...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- at registration
- Patient has given written informed consent before registration
- Female patients; eligible for primary ALND or sentinel lymph node procedure with frozen section and either:
- newly diagnosed
- or recurrent breast cancer in the conserved breast, chest wall or axilla
- Patients with histo- or cytology proven breast cancer UICC/AJCC stage I-III
- Age ≥ 18 years
- Fluency in either German, French, Italian, Spanish, Turkish or English
- The EQ-5D questionnaire has been completed at registration
- Patient with child-bearing potential, willing to use effective contraception, not currently pregnant and agreeing not to become pregnant after trial registration and during the 24 weeks after surgery
- A negative pregnancy test within 14 days prior to inclusion is available for all women with child-bearing potential
- Inclusion criteria at randomization
- \- ALND indicated according to clinical standards, either as single procedure or in combination with breast conserving surgery
- Exclusion Criteria at registration:
- Known hypersensitivity for TachoSil® or fibrin sealant
- Patients with mastectomy (simultaneously or within 1 month before registration); patients undergoing completion mastectomy at a later day will remain eligible and are evaluable for analysis according to intention to treat. If the axillary drain is still in place at the time of completion mastectomy and a separate drain is inserted underneath the skin flaps, only the axillary drain will be considered
- Prior axillary dissection (except prior sentinel node procedure)
- Prior axillary radiotherapy
- Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QoL forms
- Concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days prior to trial entry
Exclusion
Key Trial Info
Start Date :
March 18 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2017
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT02311543
Start Date
March 18 2015
End Date
June 27 2017
Last Update
May 15 2019
Active Locations (16)
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1
Kantonsspital Aarau
Aarau, Switzerland, 5001
2
Kantonsspital Baden
Baden, Switzerland, 5404
3
Universitätsspital Basel
Basel, Switzerland, 4031
4
CSSI Bellinzona/Lugano, Ospedale San Giovanni
Bellinzona, Switzerland, 6500