Trial Outcomes & Findings for Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients (NCT NCT01027416)
NCT ID: NCT01027416
Last Updated: 2017-12-13
Results Overview
Status of estrogen receptor alpha (ERά) and tumor protein (p53) interaction in p53-wild type breast tumors in untreated patients verses patients treated with tamoxifen. Mean percent positive polylactide (PLA) of all p53-wild type breast tumors in participants by treatment arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
2 years
Results posted on
2017-12-13
Participant Flow
Participant milestones
| Measure |
No Intervention
No Intervention: Standard of care
|
Tamoxifen
Tamoxifen 20 mg orally 1x/day for 4 weeks
Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
28
|
|
Overall Study
COMPLETED
|
30
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
No Intervention
No Intervention: Standard of care
|
Tamoxifen
Tamoxifen 20 mg orally 1x/day for 4 weeks
Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
4
|
Baseline Characteristics
Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
No Intervention
n=31 Participants
No Intervention: Standard of care
|
Tamoxifen
n=28 Participants
Tamoxifen 20 mg orally 1x/day for 4 weeks
Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
57.0 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All patients with p53-wild type breast tumors
Status of estrogen receptor alpha (ERά) and tumor protein (p53) interaction in p53-wild type breast tumors in untreated patients verses patients treated with tamoxifen. Mean percent positive polylactide (PLA) of all p53-wild type breast tumors in participants by treatment arm
Outcome measures
| Measure |
No Intervention
n=23 Participants
No Intervention: Standard of care
|
Tamoxifen
n=12 Participants
Tamoxifen 20 mg orally 1x/day for 4 weeks
Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
|
|---|---|---|
|
Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm
|
27.0 percentage of positive PLA
Standard Deviation 34.4
|
4.4 percentage of positive PLA
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: All patients with p53-wild type breast tumors that had RNA samples available
Total number of over-expressed genes, across all participants with tumor protein p53-wild type breast tumors that had ribonucleic acid (RNA) samples available.
Outcome measures
| Measure |
No Intervention
n=20 Participants
No Intervention: Standard of care
|
Tamoxifen
n=15 Participants
Tamoxifen 20 mg orally 1x/day for 4 weeks
Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
|
|---|---|---|
|
Total Number of Over-expressed Genes, Across All Participants With Tumor Protein p53-wild Type Breast Tumors That Had RNA Samples Available.
|
196 genes
|
256 genes
|
Adverse Events
No Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Tamoxifen
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Intervention
n=31 participants at risk
No Intervention: Standard of care
|
Tamoxifen
n=28 participants at risk
Tamoxifen 20 mg orally 1x/day for 4 weeks
Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1
|
0.00%
0/28
|
Other adverse events
| Measure |
No Intervention
n=31 participants at risk
No Intervention: Standard of care
|
Tamoxifen
n=28 participants at risk
Tamoxifen 20 mg orally 1x/day for 4 weeks
Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/31
|
14.3%
4/28 • Number of events 6
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/31
|
17.9%
5/28 • Number of events 5
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Eye disorders
Visual impairment
|
0.00%
0/31
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/31
|
17.9%
5/28 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31
|
3.6%
1/28 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31
|
21.4%
6/28 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31
|
10.7%
3/28 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/31
|
25.0%
7/28 • Number of events 10
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/31
|
17.9%
5/28 • Number of events 5
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31
|
17.9%
5/28 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31
|
7.1%
2/28 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/31
|
21.4%
6/28 • Number of events 8
|
|
General disorders
Fatigue
|
0.00%
0/31
|
10.7%
3/28 • Number of events 4
|
|
General disorders
Irritability
|
0.00%
0/31
|
28.6%
8/28 • Number of events 10
|
|
General disorders
Oedema peripheral
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/31
|
14.3%
4/28 • Number of events 5
|
|
General disorders
Sensation of pressure
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Surgical failure
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Swelling
|
0.00%
0/31
|
3.6%
1/28 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Investigations
Weight increased
|
0.00%
0/31
|
7.1%
2/28 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/31
|
17.9%
5/28 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/31
|
14.3%
4/28 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/31
|
3.6%
1/28 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/31
|
14.3%
4/28 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/31
|
7.1%
2/28 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/31
|
14.3%
4/28 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/31
|
3.6%
1/28 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/31
|
17.9%
5/28 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/31
|
3.6%
1/28 • Number of events 2
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/31
|
21.4%
6/28 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31
|
10.7%
3/28 • Number of events 3
|
|
Nervous system disorders
Headache
|
0.00%
0/31
|
32.1%
9/28 • Number of events 14
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/31
|
25.0%
7/28 • Number of events 8
|
|
Nervous system disorders
Migraine
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/31
|
7.1%
2/28 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/31
|
7.1%
2/28 • Number of events 2
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/31
|
7.1%
2/28 • Number of events 2
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/31
|
3.6%
1/28 • Number of events 2
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/31
|
7.1%
2/28 • Number of events 3
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/31
|
10.7%
3/28 • Number of events 4
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/31
|
17.9%
5/28 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/31
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/31
|
32.1%
9/28 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31
|
7.1%
2/28 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31
|
10.7%
3/28 • Number of events 3
|
|
Vascular disorders
Hot flush
|
0.00%
0/31
|
25.0%
7/28 • Number of events 8
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place