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Study of Physiological and High Dose Estradiol in the Treatment of Hormone Receptor Positive Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00324259
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Neoplasms
Intervention: Drug: Estradiol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to participant enrollment on 08/03/2004 and closed to participant enrollment on 02/19/2008.

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
Arm 1 (6 mg Estradiol) 6 mg of estradiol daily (2 mg tid).
Arm 2 (30 mg Estradiol) 30 mg of estradiol. (10 mg tid)

Participant Flow:   Overall Study
    Arm 1 (6 mg Estradiol)   Arm 2 (30 mg Estradiol)
STARTED   34   32 
COMPLETED   34   32 
NOT COMPLETED   0   0 



  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
Arm 1 (6 mg Estradiol) 6 mg of estradiol daily (2 mg tid).
Arm 2 (30 mg Estradiol) 30 mg of estradiol. (10 mg tid)
Total Total of all reporting groups

Baseline Measures
   Arm 1 (6 mg Estradiol)   Arm 2 (30 mg Estradiol)   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   32   66 
Age 
[Units: Years]
Median (Full Range)
 54.7 
 (36.3 to 83.8) 
 59.5 
 (39.4 to 77.7) 
 57.1 
 (36.3 to 83.8) 
Gender 
[Units: Participants]
     
Female   34   32   66 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   34   32   66 
Site 
[Units: Participants]
     
Bone/soft tissue   18   13   31 
Visceral   5   5   10 
Both   11   14   25 
Estrogen receptor status 
[Units: Participants]
     
Negative   1   0   1 
Positive   33   32   65 
Progesterone receptor status 
[Units: Participants]
     
Negative   8   6   14 
Positive   26   26   52 


  Outcome Measures

1.  Primary:   Clinical Benefit Rate (CR Plus PR Plus SD)   [ Time Frame: 24 weeks after start of treatment ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 48 weeks ]

3.  Secondary:   Quality of Life   [ Time Frame: Baseline and Day 28 ]

4.  Secondary:   Quality of Life (FACT-B Mean Score)   [ Time Frame: Day 28 ]

5.  Secondary:   Frequency of Response to Re-treatment With the Same Aromatase Inhibitor That Immediately Preceded Treatment With Estradiol on Protocol.   [ Time Frame: 12 weeks post-treatment termination ]

6.  Secondary:   Frequency of Response to Re-treatment With Estradiol for Patients Who Have a Secondary Response to an Aromatase Inhibitor After the First Response to Estradiol.   [ Time Frame: Every 3 months ]

7.  Secondary:   Overall Survival (OS)   [ Time Frame: Until patient death ]

8.  Post-Hoc:   Metabolic Flare on FDG-PET/CT as Compared to Response   [ Time Frame: Baseline and 24 hours after administration of the first dose of estradiol ]


  Serious Adverse Events


  Other Adverse Events


  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
The slight imbalance in numbers assigned to the 2 groups was a because of yearly data and safety monitoring, which led to early closure of the 30mg group for toxicity concerns after 32 patients had been enrolled.


  More Information

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


Results Point of Contact:  
Name/Title: Dr. Matthew Ellis
Organization: Washington University School of Medicine
phone: 314-362-8866
e-mail: mjellis@bcm.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00324259     History of Changes
Other Study ID Numbers: 04-0412 / 201108392
First Submitted: May 8, 2006
First Posted: May 10, 2006
Results First Submitted: October 8, 2014
Results First Posted: February 16, 2015
Last Update Posted: February 16, 2015