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early Breast Cancer HR+, Her2-

Adapt

Adjuvant Dynamic marker-Adjusted Personalized Therapy trial optimizing risk assessment

Erkrankung: Brustkrebs (Mammakarzinom)
Start der Studie am Zentrum: 01.12.2017
Status der Studie: Rekrutierung abgeschlossen
Studiendesign: interventionell
Studienphase: Phase III
Studienart: Medikamentöse Therapie
Haupteinschlusskritieren: - Female patients, age at diagnosis 18 years
• Histologically confirmed unilateral primary invasive carcinoma of the breast
• T1 - T4 (except inflammatory breast cancer)
• All N
• Patients should be candidates for (neo) adjuvant chemotherapy according to
conventional prognostic factors
• No clinical evidence for distant metastasis (M0)
• Known HR status and HER2 status (local pathology)
• Tumor block available for central pathology review
• Performance Status ECOG

Hauptausschlusskritieren: • Known hypersensitivity reaction to the compounds or incorporated substances
• Prior malignancy with a disease-free survival of < 10 years, except curatively
treated basalioma of the skin, pTis of the cervix uteri
• Non-operable breast cancer including inflammatory breast cancer
• Previous or concurrent treatment with cytotoxic agents for any reason after
consultation with the sponsor
• Concurrent treatment with other experimental drugs. Participation in another
interventional clinical trial with or without any investigational non-marketed drug within
30 days prior to study entry (concurrent participation in non-interventional post
authorization safety studies not influencing the primary study endpoints is allowed)
• Male breast cancer
• Concurrent pregnancy; patients of childbearing potential must implement a highly
effective (less than 1% failure rate) non-hormonal contraceptive measure during the
study treatment
• Breast feeding woman
• Sequential breast cancer
• Reasons indicating risk of poor compliance
• Patients not able to consent
Prüfarzt: Dr. med. Antje Lehnert
Weitere Informationen: Re-Start der Studie im Dezember 2017. Ursprünglich seit 2012 aktiv. Wurde aufgrund von Findings im Monitoring gestoppt und mit neuem Monitoringteam wieder gestartet.

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