A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer

Phase 2

Completed

Conditions: ER Positive, Her2 Negative Breast Cancer Patients
Triple Negative Breast Cancer Patients

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
MM-121 (SAR256212) + paclitaxel	MM-121	2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
MM-121 (SAR256212) + paclitaxel	Paclitaxel	2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Paclitaxel only	Paclitaxel	Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)	At time of surgery, an expected average of 24-26 weeks	Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.

Secondary Outcome Measures

Name	Time	Method

Locations (37): Universito of Birmingham atAlabama
🇺🇸
Birmingham, Alabama, United States
Arizona Oncology Associates
🇺🇸
Tuscon, Arizona, United States
Marin Cancer Center
🇺🇸
Greenbrae, California, United States
PMK Medical Group
🇺🇸
Oxnard, California, United States
Wilshire Oncology Medical Group
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Rancho Cucamonga, California, United States
Florida Cancer Research Institute
🇺🇸
Plantation, Florida, United States
Piedmont Healthcare
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Altanta, Georgia, United States
Piedmont Fayette Hospital
🇺🇸
Fayetteville, Georgia, United States
Georgia Cancer Specialists
🇺🇸
Marietta, Georgia, United States
University Of Chicago
🇺🇸
Chicago, Illinois, United States
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Universito of Birmingham atAlabama
🇺🇸Birmingham, Alabama, United States