Breast CancerFIRSTNCT05398497
FreezIng bReaST Cancer in Brazil: a Before-after Study
A study testing Cryoablation in people with Breast Cancer and Breast Neoplasms, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Cryoablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Sep 2022to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unifocal primary invasive breast carcinoma
- 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
Who cannot join
- Multifocal or multicentric invasive breast carcinoma
- 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
Trial locations and contacts
1 site in 1 country.
Afonso P Nazário, Professor contact
Brazil1 site
Hcor
São Paulo, São Paulo, 04004-030
Vanessa M Sanvido, Phd, 551130536611, dravanessasanvido@gmail.com
Vanessa M Sanvido, PhD
About this study
Official title: Evaluation of Cryoablation in the Local Treatment of Early Breast Cancer
Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.
Read the detailed description
Purpose: To evaluate the effectiveness of cryoablation in the local treatment of breast cancer, through the absence of neoplastic cells (invasive or in situ).
Outline
- Core biopsy
- Mammogram
- Magnetic resonance imaging
- Ultrasound
- Tumor Cryoablation
- Mammogram (post-cryoablation)
- Magnetic resonance imaging (post-cryoablation)
- Ultrasound (post-cryoablation)
- Surgery
- Evaluation of outcomes
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Cryoablation
- Keywords
- cryoablation, cryotherapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDevice
Cryoablation will be performed under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Early stage breast cancer up to 2.5 cm | Experimental | Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy. Receives: Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor ablation
Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.
Measured: 1 month
Secondary outcomes (3)
Negative predictive value of magnetic resonance imaging (MRI)
Magnetic resonance imaging will be conducted between 14 to 28 days after cryoablation. Negative predictive value of MRI will be calculated according to the pathological report after the traditional surgery. Negative predictive value = number of the patients who is pathologically negative divided by the number of patients who is MRI negative.
Measured: 14 days and 28 days
Accuracy of conventional imaging methods (mammography and ultrasound)
Mammography and ultrasound will be conducted between 14 to 28 days after cryoablation. Accuracy of conventional imaging methods will be calculated according to the pathological report after the traditional surgery.
Measured: 14 days and 28 days
Measurement of the ice ball by ultrasound
To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result.
Measured: 14 days and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start15 Sep 2022 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre B Cavalcanti, PhD, Study director, Hospital do CoracaoBruna MP Vianna, Principal investigator, Hospital do CoracaoVanessa M Sanvido, PhD, Principal investigator, Hospital do CoracaoAfonso CP Nazário, Professor, Principal investigator, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398497
- Sponsor's protocol ID
- FIRST
- Acronym
- FIRST
- Status last verified
- May 2022
- First submitted
- 26 May 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to share IPD in the article publication.
Publications
Sanvido VM, Bromberg SE, Waitzberg AFL, Gomes JO, Barbante LG, Socolowski LR, Tachibana BMT, Junior AR, Miranda TA, Negrelli KDL, Martins EVDN, Santos RHN, Vianna PM, da Silva LM, Cavalcanti AB, Nazario ACP. Cryoablation for early-stage invasive breast cancer: pathologic and imaging outcomes from the prospective FIRST trial. Breast Cancer Res. 2026 May 19;28(1):128. doi: 10.1186/s13058-026-02302-y.
PubMed 42157305
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cryoablation in the Local Treatment of Early Breast Cancer
- ClinicalTrials.gov ID
- NCT05398497
- Acronym / sponsor ID
- FIRST / FIRST
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- cryoablation, cryotherapy, breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.
Detailed description
Purpose: To evaluate the effectiveness of cryoablation in the local treatment of breast cancer, through the absence of neoplastic cells (invasive or in situ).
Outline
- Core biopsy
- Mammogram
- Magnetic resonance imaging
- Ultrasound
- Tumor Cryoablation
- Mammogram (post-cryoablation)
- Magnetic resonance imaging (post-cryoablation)
- Ultrasound (post-cryoablation)
- Surgery
- Evaluation of outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early stage breast cancer up to 2.5 cm | Experimental | Device: CryoablationPatients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unifocal primary invasive breast carcinoma
- 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
Key exclusion criteria (7 listed)
- Multifocal or multicentric invasive breast carcinoma
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationCryoablation will be performed under ultrasound guidance. | Device | Early stage breast cancer up to 2.5 cm |
Primary outcome
Tumor ablation
Time frame: 1 month
Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.
3 secondary outcomes
Negative predictive value of magnetic resonance imaging (MRI)
Time frame: 14 days and 28 days
Accuracy of conventional imaging methods (mammography and ultrasound)
Time frame: 14 days and 28 days
Measurement of the ice ball by ultrasound
Time frame: 14 days and 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 42157305Sanvido VM, Bromberg SE, Waitzberg AFL, Gomes JO, Barbante LG, Socolowski LR, Tachibana BMT, Junior AR, Miranda TA, Negrelli KDL, Martins EVDN, Santos RHN, Vianna PM, da Silva LM, Cavalcanti AB, Nazario ACP. Cryoablation for early-stage invasive breast cancer: pathologic and imaging outcomes from the prospective FIRST trial. Breast Cancer Res. 2026 May 19;28(1):128. doi: 10.1186/s13058-026-02302-y.
- Individual participant dataSharing planned: Yes. There is a plan to share IPD in the article publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afonso P Nazário, Professor contact
Alexandre B Cavalcanti, PhD study director
Hospital do Coracao
Bruna MP Vianna principal investigator
Hospital do Coracao
Vanessa M Sanvido, PhD principal investigator
Hospital do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Breast Cancer and Breast Neoplasms, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa M Sanvido, PhD (551138864688, dravanessasanvido@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor ablation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.