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

Merrimack Pharmaceuticals

Status and phase: Completed; Phase 2

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

Treatments: Drug: Paclitaxel; Drug: MM-121

Study type: Interventional

Funder types: Industry

Identifiers

NCT01421472

MM-121-02-02-07 (ARD11918)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

MM-121 (SAR256212) + paclitaxel

Experimental group

Description:

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.

Treatment:

Drug: MM-121

Drug: Paclitaxel

Paclitaxel only

Active Comparator group

Description:

Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

Treatment:

Drug: Paclitaxel