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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-09-15
2024-07-15
Brief Summary
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Detailed Description
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Outline
1. Core biopsy
2. Mammogram
3. Magnetic resonance imaging
4. Ultrasound
5. Tumor Cryoablation
6. Mammogram (post-cryoablation)
7. Magnetic resonance imaging (post-cryoablation)
8. Ultrasound (post-cryoablation)
9. Surgery
10. Evaluation of outcomes
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Early stage breast cancer up to 2.5 cm
Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy.
Cryoablation
Cryoablation will be performed under ultrasound guidance.
Interventions
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Cryoablation
Cryoablation will be performed under ultrasound guidance.
Eligibility Criteria
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Inclusion Criteria
* Pathological report should be complete (with the result of ER, PR , HER2, KI67 and FISH report of ERBB2 gene if necessary)
* Maximum tumor size ≤2.5 cm in its greatest diameter
* Ultrasound visible lesion
Exclusion Criteria
* Ductal carcinoma in-situ
* Breast cancer with skin involvement
* Clinically positive axilla (N1, N2 or N3)
* Distance from lesion and skin less than 5 mm
* Prior neoadjuvant systemic therapy for breast cancer
* Distant metastasis
18 Years
ALL
No
Sponsors
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Hospital do Coracao
OTHER
Responsible Party
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Principal Investigators
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Alexandre B Cavalcanti, PhD
Role: STUDY_DIRECTOR
Hospital do Coracao
Bruna MP Vianna
Role: PRINCIPAL_INVESTIGATOR
Hospital do Coracao
Vanessa M Sanvido, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital do Coracao
Afonso CP Nazário, Professor
Role: PRINCIPAL_INVESTIGATOR
Hospital do Coracao
Locations
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Hcor
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FIRST
Identifier Type: -
Identifier Source: org_study_id
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