Overview

This trial is active, not recruiting.

Conditions er positive, her2 negative breast cancer patients, triple negative breast cancer patients
Treatments mm-121 (sar256212) plus paclitaxel, paclitaxel
Phase phase 2
Sponsor Merrimack Pharmaceuticals
Collaborator Sanofi
Start date August 2011
End date April 2014
Trial size 200 participants
Trial identifier NCT01421472, MM-121-02-02-07 (ARD11918)

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
mm-121 (sar256212) plus paclitaxel
Treatment of MM-121 (SAR256212) IV plus standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
(Active Comparator)
paclitaxel
Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

Primary Outcomes

Measure
To determine the pathologic Complete Response (pCR) rate
time frame: At time of surgery, an expected average of 24-26 weeks

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Phase 2 Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
Description This is a multicenter, open-label, randomized, Phase II study of preoperative MM-121 with paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Merrimack Pharmaceuticals.