Trial Outcomes & Findings for Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy (NCT NCT00661531)
NCT ID: NCT00661531
Last Updated: 2017-04-12
Results Overview
Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
6 months
Results posted on
2017-04-12
Participant Flow
Participant milestones
| Measure |
Estrace & Anastrozole
Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Estrace & Anastrozole
Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy
Baseline characteristics by cohort
| Measure |
Estrace & Anastrozole
n=11 Participants
Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
|
Age, Continuous
|
64 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 monthsProgression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause
Outcome measures
| Measure |
Estrace & Anastrozole
n=11 Participants
Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
|
|---|---|
|
Progression Free Survival
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsResponse rate was defined per RECIST version 1.0. In this study, response rate was defined as including patients with either a complete response (complete disappearance of all target lesions with changes confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met) or a partial response (at least 30% decrease in the sum of the longest diameter of the target lesions)
Outcome measures
| Measure |
Estrace & Anastrozole
n=11 Participants
Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
|
|---|---|
|
Response Rate
|
2 Participants
|
Adverse Events
Estrace & Anastrozole
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Estrace & Anastrozole
n=11 participants at risk
Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
|
|---|---|
|
Gastrointestinal disorders
Anal Hemorrhage
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11 • Number of events 11
|
Other adverse events
| Measure |
Estrace & Anastrozole
n=11 participants at risk
Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Estrace: Estrace 10 mg three times daily will be administered for 3 months.
Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
54.5%
6/11 • Number of events 11
|
|
Infections and infestations
Rhinitis
|
36.4%
4/11 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
63.6%
7/11 • Number of events 9
|
|
Vascular disorders
Lymphedema
|
18.2%
2/11 • Number of events 3
|
|
Vascular disorders
Edema
|
36.4%
4/11 • Number of events 5
|
|
Cardiac disorders
Hypertension
|
18.2%
2/11 • Number of events 5
|
|
Vascular disorders
Hot flashes
|
27.3%
3/11 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
36.4%
4/11 • Number of events 4
|
|
General disorders
Fatigue
|
81.8%
9/11 • Number of events 12
|
|
Psychiatric disorders
Anxiety
|
18.2%
2/11 • Number of events 2
|
|
General disorders
Chills
|
27.3%
3/11 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
1/11 • Number of events 4
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
54.5%
6/11 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
72.7%
8/11 • Number of events 10
|
|
Gastrointestinal disorders
Emesis
|
27.3%
3/11 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
27.3%
3/11 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Number of events 5
|
|
Gastrointestinal disorders
Anorexia
|
36.4%
4/11 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
36.4%
4/11 • Number of events 5
|
|
Psychiatric disorders
Depression
|
18.2%
2/11 • Number of events 2
|
|
Nervous system disorders
Neuropathy
|
18.2%
2/11 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
27.3%
3/11 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
27.3%
3/11 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Weakness generalized
|
36.4%
4/11 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
36.4%
4/11 • Number of events 11
|
|
Reproductive system and breast disorders
Breast pain
|
54.5%
6/11 • Number of events 7
|
|
Nervous system disorders
Headache
|
36.4%
4/11 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.5%
5/11 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnea
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
63.6%
7/11 • Number of events 12
|
|
Investigations
Aspartate aminotransferase elevation
|
45.5%
5/11 • Number of events 5
|
|
Investigations
Alkaline phosphotase elevation
|
63.6%
7/11 • Number of events 15
|
|
Investigations
Alanine aminotransferase elevation
|
36.4%
4/11 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
81.8%
9/11 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
27.3%
3/11 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.2%
2/11 • Number of events 6
|
|
Infections and infestations
Infection
|
18.2%
2/11 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place