Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study Estradiol Followed by Exemestane Hormone Receptor + Metastatic 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.
 
ClinicalTrials.gov Identifier: NCT01385280
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor-positive Breast Cancer
Progesterone Receptor Positive Tumor
Recurrent Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Interventions Biological: therapeutic estradiol
Drug: exemestane
Other: laboratory biomarker analysis
Other: enzyme-linked immunosorbent assay
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  23.1%
>=65 years
10
  76.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
13
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
12
  92.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
1.Primary Outcome
Title Number of Participants With Grade 4 Toxicity
Hide Description Such as deep vein thrombosis requiring hospitalization or pulmonary embolism
Time Frame By day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Patients With Change in Serum M-30 (a Marker of Mitochondrial Apoptosis) With Treatment
Hide Description [Not Specified]
Time Frame At baseline and on days, 8, 30, 60, and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Patients With Change in Number of Circulating Tumor Cells (CTC) With Treatment
Hide Description [Not Specified]
Time Frame At baseline and on days 8, 90, and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Patients With Change in Circulating Tumor Cells (CTC) Expression of M-30 With Treatment
Hide Description [Not Specified]
Time Frame At baseline and on days 8, 90, and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Circulating Tumor Cells (CTC) ER Expression With Treatment
Hide Description [Not Specified]
Time Frame At baseline and on days 8, 90, and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Circulating Tumor Cells (CTC) IGF1R Expression With Treatment
Hide Description [Not Specified]
Time Frame At baseline and on days 8, 90, and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Median Time From Entry on Study to Progression of Disease
Hide Description In weeks
Time Frame Up to 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive oral therapeutic estradiol once daily on days 1-3, twice daily on days 4-7, and thrice daily on days 8-90. Beginning on day 98, patients receive oral exemestane once daily in the absence of disease progression or unacceptable toxicity. Also laboratory biomarker analysis and enzyme-linked immunosorbent assay will be taken for correlative studies.

therapeutic estradiol: Given orally (PO)

exemestane: Given PO

laboratory biomarker analysis: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%)
Total   5/13 (38.46%) 
Gastrointestinal disorders   
Nausea   1/13 (7.69%) 
Metabolism and nutrition disorders   
Anorexia   1/13 (7.69%) 
Musculoskeletal and connective tissue disorders   
Fracture   1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion   1/13 (7.69%) 
Lung Infection   1/13 (7.69%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I
Affected / at Risk (%)
Total   4/13 (30.77%) 
Gastrointestinal disorders   
Abdominal Pain   1/13 (7.69%) 
Vomiting   1/13 (7.69%) 
Metabolism and nutrition disorders   
Weight Loss   1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion   1/13 (7.69%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Program Coordinator
Organization: University of Arizona Cancer Center
Phone: 520-626-0301
EMail: aselegue@email.arizona.edu
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01385280     History of Changes
Other Study ID Numbers: 10-0906-04
NCI-2010-02366 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
3P30CA023074 ( U.S. NIH Grant/Contract )
First Submitted: June 22, 2011
First Posted: June 30, 2011
Results First Submitted: July 2, 2018
Results First Posted: October 17, 2018
Last Update Posted: October 17, 2018