Estrogen for Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01083641
Recruitment Status : Terminated (did not meet efficacy goals after interim analysis)
First Posted : March 10, 2010
Results First Posted : March 7, 2017
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Female Breast Cancer
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
This multicenter phase 2 study was conducted through the Wisconsin Oncology Network. Subjects were recruited from February 2010 through March 2013.

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

Reporting Groups
Estrogen Therapy

Estrogen therapy

Estradiol: 10mg oral three times daily

Participant Flow:   Overall Study
    Estrogen Therapy
Withdrawal by Subject                2 

  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.
Adult women with measurable advanced TNBC.

Reporting Groups
Estrogen Therapy

Estrogen therapy

Estradiol: 10mg oral three times daily

Baseline Measures
   Estrogen Therapy 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (34 to 90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      17 100.0% 
Male      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      2  11.8% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      14  82.4% 
More than one race      0   0.0% 
Unknown or Not Reported      1   5.9% 
Region of Enrollment 
[Units: Participants]
United States   17 
Stage at Diagnosis [1] 
[Units: Participants]
Count of Participants
Stage I   3 
Stage II   9 
Stage III   4 
Stage IV   1 

Breast cancer stages:

I: tumor =<2cm and no lymph nodes involved.

II: tumor measures 2cm-5cm, or cancer has spread to lymph nodes under the arm on the same side as the breast cancer.

III: Tumor >2cm and cancer is extensive in the underarm lymph nodes, or has spread to other lymph nodes or tissues near the breast.

IV: Cancer has spread beyond the breast, underarm, and internal mammary lymph nodes to other parts of the body near to or distant from the breast.

  Outcome Measures

1.  Primary:   Determine Tumor Objective Response (OR) Rates   [ Time Frame: Up to 4 years ]

2.  Secondary:   Clinical Benefit (CB)   [ Time Frame: Up to 4 years ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 4 years ]

4.  Secondary:   Median Overall Survival (OS)   [ Time Frame: Up to 4 years ]

  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
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.

Results Point of Contact:  
Name/Title: Dr. Kari Wisinski
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-262-2876

Responsible Party: University of Wisconsin, Madison Identifier: NCT01083641     History of Changes
Other Study ID Numbers: CO09711
First Submitted: March 8, 2010
First Posted: March 10, 2010
Results First Submitted: January 13, 2017
Results First Posted: March 7, 2017
Last Update Posted: April 4, 2017