OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Section NCT
Category Gynecological tumors / Breast cancer
Subcategory Breast cancer
Trial Type Follow-Up Treatment (Metastatic Disease)
Description for experts This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) tothe standard-of-care options of fulvestrant or an aromatase inhibitor in women and menwith breast cancer whose disease has advanced on one endocrine therapy in combinationwith a CDK4/6 inhibitor.
Description for laymen This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) tothe standard-of-care options of fulvestrant or an aromatase inhibitor in women and menwith breast cancer whose disease has advanced on one endocrine therapy in combinationwith a CDK4/6 inhibitor.
JSON Data { "short_title": "OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer", "data_mode": "900", "data_mode_number": "000002327", "official_title": "A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)", "accrual_state": "stoppedTemporarily", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "second", "ctgov_number": "NCT06016738", "eudract_number": null, "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger", "description_laie_de": "Diese klinische Studie der Phase III vergleicht die Sicherheit und Wirksamkeit von Palazestrant (OP-1250) mit der Standardbehandlung mit Fulvestrant oder einem Aromatasehemmer bei Frauen und M\u00e4nnern mit Brustkrebs, deren Erkrankung unter einer endokrinen Therapie in Kombination mit einem CDK4/6-Hemmer fortgeschritten ist.", "description_laie_en": "This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) tothe standard-of-care options of fulvestrant or an aromatase inhibitor in women and menwith breast cancer whose disease has advanced on one endocrine therapy in combinationwith a CDK4/6 inhibitor.", "description_expert_de": "Diese klinische Studie der Phase III vergleicht die Sicherheit und Wirksamkeit von Palazestrant (OP-1250) mit der Standardbehandlung mit Fulvestrant oder einem Aromatasehemmer bei Frauen und M\u00e4nnern mit Brustkrebs, deren Erkrankung unter einer endokrinen Therapie in Kombination mit einem CDK4/6-Hemmer fortgeschritten ist.", "description_expert_en": "This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) tothe standard-of-care options of fulvestrant or an aromatase inhibitor in women and menwith breast cancer whose disease has advanced on one endocrine therapy in combinationwith a CDK4/6 inhibitor.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 3, "sub_cat_id": 16 }
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Short name 900-000002327