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A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer




A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer (USON 10167)

Study Description:

The purpose of this study is to demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer patients.

Inclusion Criteria:

» Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group 1) or invasive triple-negative breast cancer (Group 2)
» Free of metastatic disease
» ≥ 18 years old
» Female
» Had no prior treatment for any cancer
» Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide

Exclusion Criteria:

» Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL
» Are pregnant or breastfeeding

Locations:


Texas Oncology - Baylor Regional Medical Center at Plano
4700 Alliance Blvd.
Plano , TX 75093

Texas Oncology - Baylor Charles A. Sammons Cancer Center
3410 Worth Street
Dallas , TX 75246

Texas Oncology - Baylor Medical Center at Garland
2300 Marie Curie Blvd.
Garland , TX 75042

Texas Oncology - Baylor Regional Medical Center at Grapevine
1650 West College
Grapevine , TX 76051

Lead Principal Investigator:

Gupta, Manish, MD (Plano and Garland); Thomas Anderson, MD (Grapevine); Cynthia Osborne, MD (Dallas)



This trial is no longer available for enrollment.

Last update: December 31, 2012
† Baylor Research Institute and Texas Oncology are not affiliated. Each reviews, approves, and conducts clinical trials independently. Their clinical trials are listed together on this website for the convenience of patients.