CRYO-TOUCH: Cryoablation of the Primary Breast Tumor in Metastatic Breast Cancer (CRYO-TOUCH)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Julien PERON, MD
- Numéro de téléphone: +33 4 78 86 43 18
- E-mail: julien.peron@chu-lyon.fr
Sauvegarde des contacts de l'étude
- Nom: Thibaut REVERDY
- Numéro de téléphone: +33 4 78 86 43 18
- E-mail: thibaut.reverdy@chu-lyon.fr
Lieux d'étude
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Lyon, France, 69 495
- Centre Hospitalier Lyon-Sud
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Contact:
- Julien PERON, PR
- Numéro de téléphone: +33 4 78 86 43 18
- E-mail: julien.peron@chu-lyon.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Female aged ≥18 years.
- Histologically confirmed metastatic breast carcinoma, regardless of histological subtype, hormone receptor status, HER2 status, or tumor grade.
- Receiving systemic anticancer treatment for metastatic breast cancer, including chemotherapy, immunotherapy, endocrine therapy, targeted therapy, or combination regimens.
- Clinical response or stable disease according to RECIST v1.1 on the most recent imaging assessment performed within 3 months before enrollment, except for the primary breast lesion, which may be progressing.
- Eligible for cryoablation of the primary breast tumor:
- ECOG Performance Status ≤2.
- Effective contraception for women of childbearing potential.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Contraindication to cryoablation according to the investigator and/or interventional radiologist.
- Contraindication to gadolinium-enhanced breast MRI according to institutional practice and radiologist assessment.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical study with an ongoing exclusion period or that could interfere with the present study according to investigator judgment.
- Psychiatric disorder or any medical condition that, in the opinion of the investigator, could compromise study participation or compliance with study procedures.
- Adults under legal protection or unable to provide informed consent.
- Persons deprived of liberty by judicial or administrative decision.
- Absence of health insurance coverage.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: Cryoablation
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.
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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.
Assessment of patient-reported outcomes including quality of life (BREAST-Q questionnaire), pain evaluation, and patient experience questionnaires evaluating acceptability and appropriateness of cryoablation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Ipsilateral Breast Tumor Recurrence at 12 Months
Délai: 12 months after cryablation
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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.
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12 months after cryablation
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 69HCL25_0566
Informations sur les médicaments et les dispositifs, documents d'étude
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