Trial Outcomes & Findings for Pilot Study Estradiol Followed by Exemestane Hormone Receptor + Metastatic Breast Cancer (NCT NCT01385280)
NCT ID: NCT01385280
Last Updated: 2018-10-17
Results Overview
Such as deep vein thrombosis requiring hospitalization or pulmonary embolism
COMPLETED
NA
13 participants
By day 90
2018-10-17
Participant Flow
Participant milestones
| Measure |
Arm I
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 Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study Estradiol Followed by Exemestane Hormone Receptor + Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=13 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: By day 90Population: Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Such as deep vein thrombosis requiring hospitalization or pulmonary embolism
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and on days, 8, 30, 60, and 90Population: Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and on days 8, 90, and 180Population: Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and on days 8, 90, and 180Population: Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and on days 8, 90, and 180Population: Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and on days 8, 90, and 180Population: Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1.5 yearsPopulation: Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.
In weeks
Outcome measures
Outcome data not reported
Adverse Events
Arm I
Serious adverse events
| Measure |
Arm I
n=13 participants at risk
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
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
7.7%
1/13
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13
|
Other adverse events
| Measure |
Arm I
n=13 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
7.7%
1/13
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Weight Loss
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.7%
1/13
|
Additional Information
Program Coordinator
University of Arizona Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place