Trial Outcomes & Findings for Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy (NCT NCT02595372)
NCT ID: NCT02595372
Last Updated: 2021-12-15
Results Overview
pCR is defined as no invasive disease in the breast of axilla at the time of definitive surgery. A patient is considered to have FASN expression if the positivity was \>= 15% at the baseline or after 4-7 days of Omeprazole monotherapy. FASN expression is evaluated using immunohistochemistry in core biopsy samples. The percent of patients with FASN expression that have pCR will be calculated with an exact 95% confidence interval.
COMPLETED
PHASE2
42 participants
Up to 6 months
2021-12-15
Participant Flow
Participant milestones
| Measure |
High Dose Omeprazole Treatment
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
High Dose Omeprazole Treatment
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy
Baseline characteristics by cohort
| Measure |
High Dose Omeprazole Treatment
n=42 Participants
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0-Fully active
|
36 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1-Restricted in physically strenuous activity
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Patients who had surgery and positive FASN expression
pCR is defined as no invasive disease in the breast of axilla at the time of definitive surgery. A patient is considered to have FASN expression if the positivity was \>= 15% at the baseline or after 4-7 days of Omeprazole monotherapy. FASN expression is evaluated using immunohistochemistry in core biopsy samples. The percent of patients with FASN expression that have pCR will be calculated with an exact 95% confidence interval.
Outcome measures
| Measure |
High Dose Omeprazole Treatment
n=29 Participants
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
Percentage of Patients With Pathological Complete Response (pCR) in Patients Who Have Fatty Acid Synthase (FASN) Expression
|
72.4 percentage of participants
Interval 52.8 to 87.3
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Patients who received surgery
pCR is defined as no invasive disease in the breast or axilla at the time of definitive surgery. The percentage of patients who achieve pCR along with exact 95% confidence intervals were calculated.
Outcome measures
| Measure |
High Dose Omeprazole Treatment
n=39 Participants
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
Percentage of Patients With Pathological Complete Response (pCR) in All Patients
|
74.4 percentage of participants
Interval 57.9 to 87.0
|
SECONDARY outcome
Timeframe: up to 1 weekPopulation: Patients with FASN positivity results at either baseline or after 4-7 days of treatment.
FASN expression was evaluated using immunohistochemistry in core biopsy samples. FASN expression was determined if the positivity was \>= 15%. The percent of patients who had FASN expression and the exact 95% confidence intervals were calculated.
Outcome measures
| Measure |
High Dose Omeprazole Treatment
n=30 Participants
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
Percent of Patients With FASN Expression
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
SECONDARY outcome
Timeframe: baseline and after 4-7 daysPopulation: Patients with FASN positivity expression at both baseline and after 4-7 days of treatment.
The mean and standard deviation of FASN positivity expression determined at baseline and after 4-7 days of Omeprazole treatment. FASN expression is evaluated using immunohistochemistry in core biopsy samples.
Outcome measures
| Measure |
High Dose Omeprazole Treatment
n=24 Participants
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
FASN Positivity Expression at Baseline and After 4-7 Days of Omeprazole Treatment
Baseline
|
53.9 percentage of positivity
Standard Deviation 23.6
|
|
FASN Positivity Expression at Baseline and After 4-7 Days of Omeprazole Treatment
After 4-7 days
|
41.7 percentage of positivity
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: baseline and after 4-7 daysPopulation: Patients with FASN activity evaluated at baseline and after 4-7 days of treatment.
The mean and standard deviation of FASN activity determined at baseline and after 4-7 days of Omeprazole treatment. FASN activity was evaluated using immunohistochemistry in core biopsy samples.
Outcome measures
| Measure |
High Dose Omeprazole Treatment
n=12 Participants
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
FASN Activity at Baseline and After 4-7 Days of Omeprazole Treatment
Baseline
|
2.1 ng/mg
Standard Deviation 1.61
|
|
FASN Activity at Baseline and After 4-7 Days of Omeprazole Treatment
After 4-7 days
|
1.3 ng/mg
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: up to 8 monthsPopulation: Patients who received treatment
Number of unique patients who had an Omeprazole treatment related (possible, probable or definite) adverse event with grade \>= 3.
Outcome measures
| Measure |
High Dose Omeprazole Treatment
n=42 Participants
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
Number of Patients With Treatment Related Adverse Events Grade 3 or Above
|
0 Participants
|
Adverse Events
High Dose Omeprazole Treatment
Serious adverse events
| Measure |
High Dose Omeprazole Treatment
n=42 participants at risk
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
3/42 • Up to 8 months
|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/42 • Up to 8 months
|
|
Investigations
Neutrophil count decreased
|
2.4%
1/42 • Up to 8 months
|
|
Investigations
White blood cell decreased
|
2.4%
1/42 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Up to 8 months
|
Other adverse events
| Measure |
High Dose Omeprazole Treatment
n=42 participants at risk
Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
31.0%
13/42 • Up to 8 months
|
|
Gastrointestinal disorders
Constipation
|
23.8%
10/42 • Up to 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
26.2%
11/42 • Up to 8 months
|
|
Gastrointestinal disorders
Dry mouth
|
9.5%
4/42 • Up to 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
4/42 • Up to 8 months
|
|
Gastrointestinal disorders
Mucositis oral
|
23.8%
10/42 • Up to 8 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
14/42 • Up to 8 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
7/42 • Up to 8 months
|
|
General disorders
Edema limbs
|
7.1%
3/42 • Up to 8 months
|
|
General disorders
Fatigue
|
38.1%
16/42 • Up to 8 months
|
|
General disorders
Pain
|
14.3%
6/42 • Up to 8 months
|
|
Infections and infestations
Urinary tract infection
|
9.5%
4/42 • Up to 8 months
|
|
Investigations
Alanine aminotransferase increased
|
11.9%
5/42 • Up to 8 months
|
|
Investigations
Lymphocyte count decreased
|
23.8%
10/42 • Up to 8 months
|
|
Investigations
Neutrophil count decreased
|
19.0%
8/42 • Up to 8 months
|
|
Investigations
Platelet count decreased
|
7.1%
3/42 • Up to 8 months
|
|
Investigations
Weight loss
|
7.1%
3/42 • Up to 8 months
|
|
Investigations
White blood cell decreased
|
16.7%
7/42 • Up to 8 months
|
|
Metabolism and nutrition disorders
Anorexia
|
21.4%
9/42 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
3/42 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
7.1%
3/42 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
6/42 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.5%
4/42 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
6/42 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
4/42 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.9%
5/42 • Up to 8 months
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • Up to 8 months
|
|
Nervous system disorders
Dysgeusia
|
9.5%
4/42 • Up to 8 months
|
|
Nervous system disorders
Headache
|
19.0%
8/42 • Up to 8 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.5%
4/42 • Up to 8 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
38.1%
16/42 • Up to 8 months
|
|
Psychiatric disorders
Anxiety
|
9.5%
4/42 • Up to 8 months
|
|
Psychiatric disorders
Insomnia
|
21.4%
9/42 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.2%
11/42 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
7/42 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.0%
13/42 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
7/42 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
7.1%
3/42 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
11.9%
5/42 • Up to 8 months
|
|
Vascular disorders
Hot flashes
|
9.5%
4/42 • Up to 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place