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NCT Number: NCT01421472

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

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.

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Key information

Conditions

ER Positive, Her2 Negative Breast Cancer Patients Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Cancer Patients

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Universito of Birmingham atAlabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MM-121

Drug

MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses

Other names: SAR256212

paclitaxel

Drug

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

Primary outcomes

  1. Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Merrimack Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Aug 22, 2011
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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