{"id":4925,"date":"2024-03-12T15:48:10","date_gmt":"2024-03-12T14:48:10","guid":{"rendered":"https:\/\/studienportal-brustkrebs.de\/providence-study\/"},"modified":"2025-07-30T11:48:17","modified_gmt":"2025-07-30T09:48:17","slug":"providence-study","status":"publish","type":"post","link":"https:\/\/studienportal-brustkrebs.de\/en\/providence-study\/","title":{"rendered":"PROVIDENCE Study"},"content":{"rendered":"\t\t
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PROVIDENCE Study<\/strong><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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A non-interventional study to collect clinical and quality of life data in patients with HER2+ or HER2-low inoperable or metastatic breast cancer who receive trastuzumab deruxtecan as second-line treatment (for HER2+) or trastuzumab deruxtecan in any line of therapy (for HER2-low) according to the professional information in routine clinical practice<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The PROVIDENCE study is a purely observational study to evaluate the efficacy and safety of trastuzumab deruxtecan<\/em> (T-DXd) in patients with documented human epidermal growth factor receptor 2 (HER2)-positive or HER2-low inoperable or metastatic breast cancer who receive T-DXd according to the applicable product information in routine clinical practice in Germany. In addition, the quality of life reported by the participating patients in this patient collective will be investigated. Furthermore, patients will be informed about the use of the digital health application (DiGA). <\/p>

What is the aim of the study?<\/strong><\/p>

The primary objective of this study is to determine the time between the start of therapy with T-<\/span>DXd<\/span> and the start of a subsequent therapy. The observation period is a maximum of 5 years. Among other things, the health-related quality of life of the <\/span>patients<\/span> is also surveyed and their possible changes during the course of therapy are evaluated. In addition, the period in which the disease does not progress further is evaluated. <\/span><\/span> <\/span><\/p>

How is the study conducted?<\/strong><\/p>

Participants are divided into two cohorts based on their tumor biology (HER2 status):<\/span> <\/span><\/p>

Cohort 1 \u2013 Patients with confirmed HER2-positive inoperable or metastatic breast cancer who receive T-DXd according to routine clinical practice.<\/span> <\/span><\/p>

Cohort 2 \u2013 Patients with confirmed inoperable or metastatic breast cancer with low HER2 status (HER2-low) who are treated with T-DXd in routine clinical practice.<\/span> <\/span><\/p>

Are there any risks?<\/strong><\/p>

You will be informed about possible risks associated with participation during an explanatory discussion. Since this registry is purely a documentation of clinical routine without planned additional treatment, there is no additional health risk associated with participation. <\/p>

Participation requirements<\/strong><\/p>

Women and men aged 18 years or older can participate in this study, with: <\/span> <\/span><\/p>