Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy
NCT ID: NCT06131632
Last Updated: 2024-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2024-03-01
2028-01-01
Brief Summary
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Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy.
In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response.
There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Breast conserving surgery
Breast conserving surgery
Remove only a small part of the breast
Radical modified mastectomy
Radical modified mastectomy
Remove all the breast parenchyma, nipple and skin
Interventions
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Breast conserving surgery
Remove only a small part of the breast
Radical modified mastectomy
Remove all the breast parenchyma, nipple and skin
Eligibility Criteria
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Inclusion Criteria
* Clinical complete response after neoadjuvant chemiotherapy
* Targeted tumor
* Written informed consent
Exclusion Criteria
* Progression disease
* Recurrent disease
* Contraindications to adjuvant radiation therapy
18 Years
70 Years
FEMALE
Yes
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Locations
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Fondazione Policlinico Universitario A. Gemelli IRCCS,
Roma, , Italy
Countries
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Facility Contacts
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Lorenzo Scardina
Role: backup
Other Identifiers
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Consibrec Trial
Identifier Type: -
Identifier Source: org_study_id
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