NCT01835236 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
Trastuzumab & Pertuzumab Followed by T-DM1 in MBC (NCT01835236)

Trial Description
In HER2-positive metastatic breast cancer, trastuzumab (Herceptin®;Genentech, Inc.) based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate.

This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab (Perjeta®; Genentech, Inc.), a treatment without chemotherapy. In case of disease progression, chemotherapy with ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician’s discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.

This trial is sponsored by Swiss Group for Clinical Cancer Research. [1]

Study Data

Study Schematic

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Last Editorial review: July 28, 2015
Information based on (NIH/NCI) and other sources.

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