Women with metastatic breast cancer needed for trial

The Marianne trial is an international trial which will involve up to 1092 patients with HER2-positive breast cancer.

The study aims to evaluate the efficacy and safety of using a new drug known T-DM1. 

T-DM1 is a new compound which consists of trastuzumab (Herceptin®), a linker molecule and the cytotoxic (chemotherapeutic) agent DM1.

This study aims to assess the safety and efficacy of T-DM1 alone, or in combination with the drug, pertuzumab, when given after surgery or radiotherapy for the treatment of metastatic breast cancer.  These results will be compared with those for women given trastuzumab [Herceptin] plus a Taxane.

To be eligible for this study, participants must have:
●    progressive or recurrent locally advanced or previously untreated metastatic breast cancer. 

Patients who have received trastuzumab and/or paclitaxel / docetaxel in the past may be able to be included in this study.

Patients with available standard curative options will not be eligible for this trial.

Trastuzumab (Herceptin®), an antibody targeting HER2-positive breast cancer, is commonly used in combination with the standard chemotherapy for this type of patient.

Like trastuzumab, the study drug pertuzumab also acts on HER2-positive cells. In previous studies, an “add on” effect was seen when trastuzumab and pertuzumab were given together.

This study will compare the use T-DM1 alone, or in combination with pertuzumab when given after surgery or radiotherapy for the treatment of metastatic breast cancer.  These results will be compared with those for women given trastuzumab (Herceptin®) plus a taxane.

This trial is now closed and in follow-up.

For further information visit this page on the Marianne Study BO22589  

 

May 2011