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
Results First Received: February 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: ER Positive, Her2 Negative Breast Cancer Patients
Triple Negative Breast Cancer Patients
Interventions: Drug: MM-121
Drug: Paclitaxel

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HR+: MM-121+ Paclitaxel

Hormone-receptor positive (HR+) sub-group randomized to receive:

2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)

HR+: Paclitaxel Only

Hormone-receptor positive (HR+) sub-group randomized to receive:

Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

TN: MM-121 + Paclitaxel

Triple Negative (TN) patients randomized to receive:

2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)

TN: Paclitaxel

Triple negative (TN) patients randomized to receive:

Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.


Participant Flow:   Overall Study
    HR+: MM-121+ Paclitaxel     HR+: Paclitaxel Only     TN: MM-121 + Paclitaxel     TN: Paclitaxel  
STARTED     67     33     64     32  
COMPLETED     67     33     64     32  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
HR+: MM-121+ Paclitaxel

Hormone-receptor positive (HR+) sub-group randomized to receive:

2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)

HR+: Paclitaxel Only

Hormone-receptor positive (HR+) sub-group randomized to receive:

Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

TN: MM-121 + Paclitaxel

Triple Negative (TN) patients randomized to receive:

2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)

TN: Paclitaxel

Triple negative (TN) patients randomized to receive:

Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

Total Total of all reporting groups

Baseline Measures
    HR+: MM-121+ Paclitaxel     HR+: Paclitaxel Only     TN: MM-121 + Paclitaxel     TN: Paclitaxel     Total  
Number of Participants  
[units: participants]
  67     33     64     32     196  
Age  
[units: years]
Mean (Standard Deviation)
  50.7  (10.35)     48.9  (10.53)     49.3  (10.89)     52.5  (13.45)     50.25  (11.12)  
Gender  
[units: participants]
         
Female     67     33     64     32     196  
Male     0     0     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     10     10     13     3     36  
Not Hispanic or Latino     57     22     51     29     159  
Unknown or Not Reported     0     1     0     0     1  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     1     0     0     0     1  
Native Hawaiian or Other Pacific Islander     0     1     0     0     1  
Black or African American     7     4     11     5     27  
White     57     26     48     26     157  
More than one race     0     0     0     0     0  
Unknown or Not Reported     2     2     5     1     10  
Region of Enrollment  
[units: participants]
         
United States     67     33     64     32     196  
Subject of Child-Bearing Potential (Y/N)  
[units: participants]
         
Yes     32     19     27     12     90  
No     35     14     37     20     106  



  Outcome Measures

1.  Primary:   Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)   [ Time Frame: At time of surgery, an expected average of 24-26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: NCT01421472     History of Changes
Other Study ID Numbers: MM-121-02-02-07 (ARD11918)
Study First Received: August 19, 2011
Results First Received: February 14, 2016
Last Updated: March 30, 2016
Health Authority: United States: Food and Drug Administration