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Estrogen for Triple Negative Breast Cancer

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ClinicalTrials.gov 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
Sponsor:
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
Enrollment 17
Recruitment Details This multicenter phase 2 study was conducted through the Wisconsin Oncology Network. Subjects were recruited from February 2010 through March 2013.
Pre-assignment Details  
Arm/Group Title Estrogen Therapy
Hide Arm/Group Description

Estrogen therapy

Estradiol: 10mg oral three times daily

Period Title: Overall Study
Started 17
Completed 15
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Estrogen Therapy
Hide Arm/Group Description

Estrogen therapy

Estradiol: 10mg oral three times daily

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
Adult women with measurable advanced TNBC.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants
57.9
(34 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
17
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
Stage at Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Stage I
3
  17.6%
Stage II
9
  52.9%
Stage III
4
  23.5%
Stage IV
1
   5.9%
[1]
Measure Description:

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.

1.Primary Outcome
Title Determine Tumor Objective Response (OR) Rates
Hide Description OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Therapy
Hide Arm/Group Description:

Estrogen therapy

Estradiol: 10mg oral three times daily

Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.9
(0.2 to 28.7)
2.Secondary Outcome
Title Clinical Benefit (CB)
Hide Description Defined as complete response, partial response, or stable disease at > 16 weeks
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Therapy
Hide Arm/Group Description:

Estrogen therapy

Estradiol: 10mg oral three times daily

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
1
   5.9%
Stable Disease at > 16 weeks
1
   5.9%
Stable Disease < 16 weeks
2
  11.8%
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description [Not Specified]
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Therapy
Hide Arm/Group Description:

Estrogen therapy

Estradiol: 10mg oral three times daily

Overall Number of Participants Analyzed 17
Median (95% Confidence Interval)
Unit of Measure: months
1.9
(1.3 to 4.0)
4.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Therapy
Hide Arm/Group Description:

Estrogen therapy

Estradiol: 10mg oral three times daily

Overall Number of Participants Analyzed 17
Median (95% Confidence Interval)
Unit of Measure: months
7.6
(3.9 to 20.4)
Time Frame Adverse event data was collected for 4 years.
Adverse Event Reporting Description Toxicity evaluations including history, examination, and laboratory analysis occurred on day 1 of each cycle.
 
Arm/Group Title Estrogen Therapy
Hide Arm/Group Description

Estrogen therapy

Estradiol: 10mg oral three times daily

All-Cause Mortality
Estrogen Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Estrogen Therapy
Affected / at Risk (%) # Events
Total   4/17 (23.53%)    
Blood and lymphatic system disorders   
Hemorrhage  1  1/17 (5.88%)  1
Cardiac disorders   
Supraventricular and nodal arrhythmia  1  1/17 (5.88%)  1
Gastrointestinal disorders   
Nausea  1  1/17 (5.88%)  2
Vomiting  1  2/17 (11.76%)  2
General disorders   
Fatigue  1  1/17 (5.88%)  1
Fever  1  1/17 (5.88%)  1
Infections and infestations   
Infection  1  1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness  1  1/17 (5.88%)  1
Pain- back  1  1/17 (5.88%)  1
Nervous system disorders   
Dizziness  1  1/17 (5.88%)  1
Headache  1  1/17 (5.88%)  1
Seizure  1  1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/17 (11.76%)  2
Vascular disorders   
Thrombosis/Thrombus/embolism  1  1/17 (5.88%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Estrogen Therapy
Affected / at Risk (%) # Events
Total   17/17 (100.00%)    
Blood and lymphatic system disorders   
Edema: limb Count  1  6/17 (35.29%)  7
Hemoglobin Count  1  6/17 (35.29%)  7
Hemorrhage Count  1  5/17 (29.41%)  7
Leukocytes (total WBC) Count  1  3/17 (17.65%)  5
Lymphedema-related fibrosis Count  1  2/17 (11.76%)  2
Lymphopenia Count  1  1/17 (5.88%)  1
Neutrophils/granulocytes (ANC/AGC) Count  1  1/17 (5.88%)  1
Cardiac disorders   
Hypertension Count  1  1/17 (5.88%)  1
Eye disorders   
Vision-flashing lights/floaters Count  1  1/17 (5.88%)  2
Gastrointestinal disorders   
Anorexia Count  1  4/17 (23.53%)  4
Constipation Count  1  4/17 (23.53%)  5
Diarrhea Count  1  1/17 (5.88%)  2
Distension/bloating, abdominal Count  1  3/17 (17.65%)  3
Dry mouth/salivary gland (xerostomia) Count  1  1/17 (5.88%)  1
Nausea Count  1  11/17 (64.71%)  12
Vomiting Count  1  5/17 (29.41%)  5
General disorders   
Fatigue (asthenia, lethargy, malaise) Count  1  13/17 (76.47%)  23
Pain Count  1  14/17 (82.35%)  26
Weight gain Count  1  2/17 (11.76%)  2
Infections and infestations   
Infection Count  1  4/17 (23.53%)  4
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia) Count  1  10/17 (58.82%)  11
Alkaline phosphatase Count  1  1/17 (5.88%)  1
ALT, SGPT (serum glutamic pyruvic transaminase) Count  1  2/17 (11.76%)  2
AST, SGOT(serum glutamic oxaloacetic transaminase) Count  1  3/17 (17.65%)  5
Calcium, serum-low (hypocalcemia) Count  1  3/17 (17.65%)  4
Creatinine Count  1  1/17 (5.88%)  1
Glucose, serum-high (hyperglycemia) Count  1  3/17 (17.65%)  3
Glucose, serum-low (hypoglycemia) Count  1  1/17 (5.88%)  1
Potassium, serum-low (hypokalemia) Count  1  2/17 (11.76%)  4
Sodium, serum-low (hyponatremia) Count  1  1/17 (5.88%)  1
Nervous system disorders   
Confusion Count  1  1/17 (5.88%)  1
Dizziness Count  1  3/17 (17.65%)  3
Mood alteration - Anxiety Count  1  1/17 (5.88%)  1
Mood alteration - Depression Count  1  2/17 (11.76%)  2
Neuropathy: sensory Count  1  6/17 (35.29%)  8
Reproductive system and breast disorders   
Vaginal discharge (non-infectious) Count  1  4/17 (23.53%)  4
Respiratory, thoracic and mediastinal disorders   
Cough Count  1  5/17 (29.41%)  5
Dyspnea (shortness of breath) Count  1  5/17 (29.41%)  5
Pulmonary/Upper Respiratory - Other (Specify, __) Count  1  1/17 (5.88%)  1
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) Count  1  1/17 (5.88%)  1
Skin and subcutaneous tissue disorders   
Dermal change lymphedema, phlebolymphedema Count  1  1/17 (5.88%)  1
Dermatology/Skin Count  1  1/17 (5.88%)  2
Hair loss/alopecia (scalp or body) Count  1  1/17 (5.88%)  1
Pruritus/itching Count  1  1/17 (5.88%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
ClinicalTrials.gov 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