Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breast conserving surgery, Radical modified mastectomy.
- Who it may be relevant to
- Registry conditions: Inflammatory Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial
Overview
Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast. 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.
Interventions
- Procedure Breast conserving surgery
Remove only a small part of the breast - Procedure Radical modified mastectomy
Remove all the breast parenchyma, nipple and skin
Primary outcome measures
- local recurrence rate [Time frame: 24 months]
Secondary outcome measures (2)
- local recurrence-free survival [Time frame: 24 months]
- overall survival [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Patients with inflammatory breast cancer
- Clinical complete response after neoadjuvant chemiotherapy
- Targeted tumor
- Written informed consent
Exclusion criteria
- Metastasis
- Progression disease
- Recurrent disease
- Contraindications to adjuvant radiation therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS, — Roma
Identifiers
NCT: NCT06131632 · Consibrec Trial