SURVIVE

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 anti-tumor therapy (adjuvant chemotherapy, surgery or radiotherapy, whichever occurs last) to receive: - Standard Surveillance according to national guidelines or - Intensive Surveillance

{ "short_title": "SURVIVE", "data_mode": "900", "data_mode_number": "000002441", "official_title": "Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer) \u2013 a partially double-blinded, multi-center, 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-tumor 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-tumor 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-tumor 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 }