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Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Translational Breast Cancer Research Consortium
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00577122
First received: December 18, 2007
Last updated: September 24, 2014
Last verified: September 2014
Results First Received: September 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Estrogen Receptor-negative Breast Cancer
Progesterone Receptor-negative Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: Medroxyprogesterone progesterone acetate (MPA)
Drug: Medroxyprogesterone with Cyclophosphamide + Methotrexate

  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
Since there was not enough evidence of clinical benefit, this study did not go beyond the first stage in the two stage design. A total of 30 patients (14 in the MPA alone cohort and 16 in the MPA+ ldoCM cohort) were in the study before the study ended.

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
Cohort 1: MPA-Alone Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cohort 2: MPA+IdoCM

Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.

Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.


Participant Flow:   Overall Study
    Cohort 1: MPA-Alone   Cohort 2: MPA+IdoCM
STARTED   14   16 
COMPLETED   0   0 
NOT COMPLETED   14   16 
Adverse Event                0                2 
Progression, relapse during active trt                6                8 
Prog, refract disease during active trt                8                5 
Alternative Therapy                0                1 



  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.
No text entered.

Reporting Groups
  Description
Cohort 1: MPA-Alone Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cohort 2: MPA+IdoCM

Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.

Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.

Total Total of all reporting groups

Baseline Measures
   Cohort 1: MPA-Alone   Cohort 2: MPA+IdoCM   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   16   30 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   9   12   21 
>=65 years   5   4   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.0  (12.78)   56.2  (12.24)   57.5  (12.36) 
Gender 
[Units: Participants]
     
Female   14   16   30 
Male   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   14   16   30 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   5   3   8 
White   9   12   21 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 


  Outcome Measures
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1.  Primary:   Clinical Benefit Rate (CR + PR + SD > 6 Months).   [ Time Frame: baseline through end of study, up to 3 years ]

2.  Secondary:   Grade 3 or 4 Adverse Events Related to Treatment   [ Time Frame: baseline through end of treatment ]

3.  Secondary:   MPA Trough Level > 50 ng/mL When Have Clinical Benefit   [ Time Frame: baseline through end of treatment ]

4.  Secondary:   MPA Trough Concentration   [ Time Frame: Cycle 1 (Day 10-14) and Cycle 2 (Day 1) ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kathy Miller, MD
Organization: IndianaU
e-mail: kathmill@iupui.edu



Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00577122     History of Changes
Other Study ID Numbers: 0607-18 IUCRO-0154
TBCRC 007 ( Other Identifier: Translational Breast Cancer Reserach Consortium )
Study First Received: December 18, 2007
Results First Received: September 16, 2014
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board