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Metastatic breast cancer remains an incurable disease for most patients. While surgical treatment of the primary breast tumor is commonly performed in localized breast cancer, its role in metastatic breast cancer remains controversial due to the lack of demonstrated survival benefit and the potential interruption of systemic anticancer therapies.
Cryoablation is a minimally invasive outpatient procedure that destroys tumor tissue through controlled freezing. In localized breast cancer, cryoablation has shown promising results regarding local tumor control, safety, and patient quality of life. However, evidence regarding its use in metastatic breast cancer remains limited.The primary objective of this prospective single-center cohort study is to evaluate local tumor control 12 months after cryoablation of the primary breast tumor in patients with metastatic breast cancer.
Metastatic breast cancer remains an incurable disease for most patients. While surgical treatment of the primary breast tumor is commonly performed in localized breast cancer, its role in metastatic breast cancer remains controversial due to the lack of demonstrated survival benefit and the potential interruption of systemic anticancer therapies.
Cryoablation is a minimally invasive outpatient procedure that destroys tumor tissue through controlled freezing. In localized breast cancer, cryoablation has shown promising results regarding local tumor control, safety, and patient quality of life. However, evidence regarding its use in metastatic breast cancer remains limited.
Preliminary retrospective data and local clinical experience suggest that cryoablation of the primary breast tumor may be feasible, safe, and associated with favorable local control in selected patients with metastatic breast cancer. Additional prospective data are needed to better characterize its clinical outcomes and its potential role as an alternative local treatment option.
The primary objective of this prospective single-center cohort study is to evaluate local tumor control 12 months after cryoablation of the primary breast tumor in patients with metastatic breast cancer.
Secondary objectives include evaluation of procedure-related safety, postoperative complications, pain, quality of life, treatment interruption, and implementation outcomes such as acceptability, appropriateness, feasibility, fidelity, and sustainability among both patients and healthcare professionals.
The study hypothesizes that cryoablation of the primary breast tumor is associated with satisfactory local tumor control, acceptable safety, favorable quality of life outcomes, and high acceptability among patients and healthcare professionals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Other | Participants with metastatic breast cancer and an eligible primary breast tumor undergoing cryoablation as part of their clinical management. Participants will undergo cryoablation of the primary breast tumor and will be followed for 12 months. Study-specific procedures include baseline and 12-month breast MRI assessments, pain evaluations, quality-of-life questionnaires, safety assessments, and implementation questionnaires. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Procedure | Participants with metastatic breast cancer and an eligible primary breast tumor undergoing cryoablation as part of their clinical management. Participants will undergo cryoablation of the primary breast tumor and will be followed for 12 months. Study-specific procedures include baseline and 12-month breast MRI assessments, pain evaluations, quality-of-life questionnaires, safety assessments, and implementation questionnaires. |
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral Breast Tumor Recurrence at 12 Months | Presence of ipsilateral breast tumor recurrence (IBTR) 12 months after cryoablation of the primary breast tumor. IBTR is defined as invasive local recurrence identified on breast MRI and, when indicated, confirmed by biopsy. | 12 months after cryablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien PERON, MD | Contact | 4 78 86 43 18 | +33 | julien.peron@chu-lyon.fr |
| Thibaut REVERDY | Contact | 4 78 86 43 18 | +33 | thibaut.reverdy@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon-Sud | Lyon | 69 495 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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Single-center prospective cohort study. Eligible patients undergoing cryoablation of the primary breast tumor as part of routine clinical care will be enrolled and followed for 12 months. Study-specific procedures include baseline and 12-month breast MRI examinations, patient-reported outcome measures, pain assessments, safety monitoring, and implementation questionnaires.
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| Patient-Reported Outcome Assessment | Other | Assessment of patient-reported outcomes including quality of life (BREAST-Q questionnaire), pain evaluation, and patient experience questionnaires evaluating acceptability and appropriateness of cryoablation. |
|
| D017437 |
| Skin and Connective Tissue Diseases |