DYNASTY-Breast02

Reason for the study: You have breast cancer with one or more hormone receptor-positive (HR+) breast tumors and are being treated with standard therapy. The sponsor named above is currently developing a new therapy. Therefore, the investigational drug called DB-1303 will be tested in the study. The sponsor wants to determine whether the investigational drug is effective compared to standard therapy and whether it is safe for patients with your type of breast cancer. The investigational drug being tested: DB-1303 is still in clinical trials and has not yet been approved for your treatment. As of December 14, 2023, approximately 235 people have received DB-1303.

{ "short_title": "DYNASTY-Breast02 ", "data_mode": "900", "data_mode_number": "000002439", "official_title": "Eine randomisierte, multizentrische, offene Phase-III-Studie zu DB-1303 \r\nim Vergleich zu einer Chemotherapie nach Wahl des Pr\u00fcfarztes bei \r\nPatienten mit humanem epidermalem Wachstumsfaktor-Rezeptor \r\n2(HER2)-niedrigem, Hormonrezeptor-positivem (HR+) metastasiertem \r\nBrustkrebs, deren Erkrankung unter einer endokrinen Therapie (ET) \r\nfortgeschritten ist (DYNASTY-Breast02)", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "second", "ctgov_number": "NCT06018337", "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": "Grund f\u00fcr die Studie: Sie sind an Brustkrebs mit einem oder mehreren hormonrezeptorpositiven (HR+) \r\nBrusttumoren erkrankt und werden mit der Standardtherapie behandelt. Der oben genannte Sponsor \r\nentwickelt derzeit eine neue Therapie. Deswegen soll das Pr\u00fcfpr\u00e4parat mit dem Namen DB-1303 in der \r\nStudie getestet werden. Damit will der Sponsor herausfinden, ob das Pr\u00fcfpr\u00e4parat im Vergleich zur \r\nStandardtherapie wirksam und bei Patienten mit Ihrer Brustkrebsart sicher ist.\r\nDas getestete Pr\u00fcfpr\u00e4parat: DB-1303 ist noch in der klinischen Pr\u00fcfung und wurde f\u00fcr Ihre Behandlung \r\nbisher nicht zugelassen. Bis zum 14. Dezember 2023 haben etwa 235 Personen DB-1303 erhalten.", "description_laie_en": "Reason for the study: You have breast cancer with one or more hormone receptor-positive (HR+) breast tumors and are being treated with standard therapy. The sponsor named above is currently developing a new therapy. Therefore, the investigational drug called DB-1303 will be tested in the study. The sponsor wants to determine whether the investigational drug is effective compared to standard therapy and whether it is safe for patients with your type of breast cancer.\r\nThe investigational drug being tested: DB-1303 is still in clinical trials and has not yet been approved for your treatment. As of December 14, 2023, approximately 235 people have received DB-1303.", "description_expert_de": "Eine randomisierte, multizentrische, offene Phase-III-Studie zu DB-1303 im Vergleich zu einer Chemotherapie nach Wahl des Pr\u00fcfarztes bei Patienten mit humanem epidermalem Wachstumsfaktor-Rezeptor 2(HER2)-niedrigem, Hormonrezeptor-positivem (HR+) metastasiertem Brustkrebs, deren Erkrankung unter einer endokrinen Therapie (ET) fortgeschritten ist.", "description_expert_en": "A randomized, multicenter, open-label, phase III study of DB-1303 versus investigator-choice chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-low, hormone receptor-positive (HR+) metastatic breast cancer whose disease has progressed on endocrine therapy.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 3, "sub_cat_id": 16 }