A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab Plus a Taxane in Patients With Metastatic Breast Cancer (MARIANNE) (NCT01120184)
This randomized, 3-arm, multicentre, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in patients with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Patients will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded. This trial is sponsored by Roche/Genetech.
- Condition: Breast Cancer
- Phase: III
- Enrollment: 1.095
- Start: July 2010
- Estimated Completion: February 2016
- Last verified: January 2015
Study schematic (Click on image to enlarge)
This study is ongoing. However, interim results presented during the 2015 Annual Meeting of the American Society of Clinical Oncology revealed that the study met the PFS non-inferiority end point, but not the superiority end point. OS was similar across all treatment arms.
PFS was 13.7 months in the standard treatment group, 14.1 in the ado-trastuzumab emtansine alone group, and 15.2 in the group treated with ado-trastuzumab emtansine + pertuzumab.
The ado-trastuzumab emtansine containing groups did see an overall lower percentage of grade 3-5 adverse events when compared to the standard treatment group. The percentage of these adverse events was lower in the ado-trastuzumab emtansine alone group and the ado-trastuzumab emtansine + pertuzumab group by 8.7% and 7.9%, respectively. Neutropenia, the most common adverse event in all groups, was 19.8% in the standard treatment group, 4.4% in the ado-trastuzumab emtansine alone group, and 2.7% in the ado-trastuzumab emtansine+ pertuzumab group. However, the researchers noted that some adverse events such as thrombocytopenia and anemia were higher in the ado-trastuzumab emtansine containing groups.
Last Editorial review: June 29, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.