Detect V Study

Breast cancer is classified into different subgroups based on specific characteristics of the tumor. This is important for targeted therapy and prognosis. For the Detect V study, two criteria must be met: The tumor must be positive for the HER2 growth factor, and the tumor must already be locally advanced or metastatic. This generally means that the tumor is no longer curable. A common treatment in such cases is antibody therapy combined with a medication (Kisqali®) that inhibits the proliferation of tumor cells. In addition, chemotherapy or hormone therapy is administered. In addition to efficacy, the tolerability and safety of a treatment—including what is known as toxicity—also play a major role.

The goal of the Detect V study is to investigate the tolerability and safety of the various treatment modalities. You will therefore receive an antibody and, in addition, EITHER chemotherapy OR hormone therapy. Six different drugs are used for chemotherapy, and the same number for hormone therapy. Whether you receive chemotherapy OR hormone therapy—and which of the six drugs in each case—is determined at random; however, you and your doctor will know which treatment you are receiving (this is an open-label study). There are thus a total of 12 different treatment options; treatment is administered according to the regimen already established for each drug. Tolerability and safety are assessed 3–9 weeks after the end of treatment. The study is now complete.

Hormone therapy will then continue. Patients who receive chemotherapy as part of the study will also receive hormone therapy 3 weeks after the end of chemotherapy as so-called maintenance therapy. These patients will not receive Kisqali® until this point.

Facts:

• What disease: Breast cancer (women only) • Cancer characteristics: HER2-positive, locally advanced, or metastatic • What the study is investigating: Antibody + Kisqali® with EITHER standard chemotherapy OR standard hormone therapy. No new medication • Study objective: To evaluate the tolerability and safety of the medications used • Study duration: approximately 9 weeks • Study characteristics: random assignment to study arm (randomization), no blinding