Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01151046
First received: June 24, 2010
Last updated: April 11, 2016
Last verified: April 2016
Results First Received: February 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Her2 Negative Breast Cancer Patients
Interventions: Drug: MM-121
Drug: Placebo
Drug: Exemestane

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
MM-121 + Exemestane MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
Placebo + Exemestane Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day

Participant Flow:   Overall Study
    MM-121 + Exemestane     Placebo + Exemestane  
STARTED     59     59  
COMPLETED     56     59  
NOT COMPLETED     3     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
MM-121 + Exemestane MM-121 and Exemestane: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
Placebo + Exemestane Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
Total Total of all reporting groups

Baseline Measures
    MM-121 + Exemestane     Placebo + Exemestane     Total  
Number of Participants  
[units: participants]
  56     59     115  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     33     41     74  
>=65 years     23     18     41  
Age  
[units: years]
Mean (Standard Deviation)
  62.8  (10.43)     60.5  (9.13)     61.6  (9.81)  
Gender  
[units: participants]
     
Female     56     59     115  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     3     4  
Not Hispanic or Latino     55     56     111  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     2     2  
Black or African American     2     0     2  
White     54     57     111  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Bone-Only Disease (Y/N)  
[units: participants]
     
Bone-Only (Yes)     12     17     29  
Bone-Only (No)     44     42     86  
Progression Setting (Adjuvant, Metastatic)  
[units: participants]
     
Adjuvant     22     22     44  
Metastatic     34     37     71  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks ]

2.  Secondary:   Overall Survival   [ Time Frame: Time from first dose to date of death, over approximately 2 years ]

3.  Post-Hoc:   To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Exemestane in Formalin Fixed (FFPE) Tumor Samples   [ Time Frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Manager
Organization: Merrimack Pharmaceuticals
phone: 617-441-1000
e-mail: smathews@merrimack.com



Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01151046     History of Changes
Other Study ID Numbers: MM-121-02-02-03 (ARD11588)
Study First Received: June 24, 2010
Results First Received: February 14, 2016
Last Updated: April 11, 2016
Health Authority: United States: Food and Drug Administration