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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01421472
First received: August 19, 2011
Last updated: March 30, 2016
Last verified: March 2016

August 19, 2011
March 30, 2016
August 2011
December 2013   (final data collection date for primary outcome measure)
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR) [ Time Frame: At time of surgery, an expected average of 24-26 weeks ] [ Designated as safety issue: No ]
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.
To Determine the Pathologic Complete Response (pCR) Rate [ Time Frame: At time of surgery, an expected average of 24-26 weeks ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01421472 on ClinicalTrials.gov Archive Site
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A 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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • ER Positive, Her2 Negative Breast Cancer Patients
  • Triple Negative Breast Cancer Patients
  • Drug: MM-121
    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 Name: SAR256212
  • Drug: Paclitaxel
    Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
  • Experimental: MM-121 (SAR256212) + 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.
    Interventions:
    • Drug: MM-121
    • Drug: Paclitaxel
  • Active Comparator: Paclitaxel only
    Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
    Intervention: Drug: Paclitaxel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01421472
MM-121-02-02-07 (ARD11918)
Yes
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Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Sanofi
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP