SURVIVE
https://www.nct-dresden.de/de/trials/900-000002441
https://www.nct-dresden.de/@@site-logo/logo-nct.svg
SURVIVE
Bereich
NCT
Kategorie
Gynäkologische Tumoren/ Mammakarzinom
Unterkategorie
Mammakarzinom
Studientyp
weitere Systemtherapie Studien
Beschreibung für Experten
This is a partially double-blinded, multi-center, randomized, controlled
superiority study to evaluate the potential benefits of intensified surveillance
versus standard surveillance in medium-risk and high-risk early breast cancer
patients.
3500 patients will be randomized in a 1:1 ratio after completion of primary antitumor therapy (adjuvant chemotherapy, surgery or radiotherapy, whichever
occurs last) to receive:
- Standard Surveillance according to national guidelines or
- Intensive Surveillance
Beschreibung
Es handelt sich um eine teilweise doppelblinde, multizentrische, randomisierte, kontrollierte Überlegenheitsstudie zur Bewertung des potenziellen Nutzens einer intensivierten Überwachung gegenüber einer Standardüberwachung bei Patientinnen mit frühem Brustkrebs mit mittlerem und hohem Risiko.
3.500 Patientinnen werden nach Abschluss der primären Antitumortherapie (adjuvante Chemotherapie, Operation oder Strahlentherapie, je nachdem, was zuletzt eintritt) im Verhältnis 1:1 randomisiert und erhalten:
– Standardüberwachung gemäß nationalen Leitlinien oder
– Intensivüberwachung
JSON Daten
{
"short_title": "SURVIVE",
"data_mode": "900",
"data_mode_number": "000002441",
"official_title": "Standard Surveillance vs. Intensive Surveillance in \r\nEarly Breast Cancer) \u2013 a partially double-blinded, multi\u0002center, randomized, controlled superiority study",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "kurativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": "NCT05658172",
"eudract_number": null,
"general_contact_email": "studiensekretariat.gyn@ukdd.de",
"general_contact_phone": "+49 351-4584202",
"hauptpruefer_dd_name": "Dr. Theresa Link",
"description_laie_de": "Es handelt sich um eine teilweise doppelblinde, multizentrische, randomisierte, kontrollierte \u00dcberlegenheitsstudie zur Bewertung des potenziellen Nutzens einer intensivierten \u00dcberwachung gegen\u00fcber einer Standard\u00fcberwachung bei Patientinnen mit fr\u00fchem Brustkrebs mit mittlerem und hohem Risiko.\r\n3.500 Patientinnen werden nach Abschluss der prim\u00e4ren Antitumortherapie (adjuvante Chemotherapie, Operation oder Strahlentherapie, je nachdem, was zuletzt eintritt) im Verh\u00e4ltnis 1:1 randomisiert und erhalten:\r\n\u2013 Standard\u00fcberwachung gem\u00e4\u00df nationalen Leitlinien oder\r\n\u2013 Intensiv\u00fcberwachung",
"description_laie_en": "This is a partially double-blinded, multi-center, randomized, controlled \r\nsuperiority study to evaluate the potential benefits of intensified surveillance \r\nversus standard surveillance in medium-risk and high-risk early breast cancer \r\npatients.\r\n3500 patients will be randomized in a 1:1 ratio after completion of primary anti\u0002tumor therapy (adjuvant chemotherapy, surgery or radiotherapy, whichever \r\noccurs last) to receive:\r\n- Standard Surveillance according to national guidelines or\r\n- Intensive Surveillance",
"description_expert_de": "This is a partially double-blinded, multi-center, randomized, controlled \r\nsuperiority study to evaluate the potential benefits of intensified surveillance \r\nversus standard surveillance in medium-risk and high-risk early breast cancer \r\npatients.\r\n3500 patients will be randomized in a 1:1 ratio after completion of primary anti\u0002tumor therapy (adjuvant chemotherapy, surgery or radiotherapy, whichever \r\noccurs last) to receive:\r\n- Standard Surveillance according to national guidelines or\r\n- Intensive Surveillance",
"description_expert_en": "This is a partially double-blinded, multi-center, randomized, controlled \r\nsuperiority study to evaluate the potential benefits of intensified surveillance \r\nversus standard surveillance in medium-risk and high-risk early breast cancer \r\npatients.\r\n3500 patients will be randomized in a 1:1 ratio after completion of primary anti\u0002tumor therapy (adjuvant chemotherapy, surgery or radiotherapy, whichever \r\noccurs last) to receive:\r\n- Standard Surveillance according to national guidelines or\r\n- Intensive Surveillance",
"rechtsgrundlage_value": "BO",
"phase_amg_value": null,
"main_cat_id": 3,
"sub_cat_id": 16
}