Trial Outcomes & Findings for A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib (NCT NCT04366713)
NCT ID: NCT04366713
Last Updated: 2023-02-10
Results Overview
The primary endpoint is to describe the changes in colon pathology between the baseline colonoscopy and the second colonoscopy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
From baseline to second colonoscopy, which is 88 days after start of neratinib treatment.
Results posted on
2023-02-10
Participant Flow
Patients with stage 1 to 3c disease receiving extended adjuvant therapy are anticipated to participate in the study for approximately 1 year: 1 month for screening and 12 months of treatment, and 1 month of safety follow up. Patients with mBC are anticipated to participate in the study for an average of 12 month: 1 month of screening, 9.5 months for treatment, and 1 month of safety follow up.
Screening activities are to be conducted within 28 days prior to Cycle 1/Day 1, except for serum or urine pregnancy test for women of child-bearing potential, which should be performed, both, at screening and repeated within 72 hours prior to Cycle 1/Day 1. Documentation of locally assessed ERBB2-amplified status by fluorescence in situ hybridization (FISH) (\>2.2) or ERBB2 overexpression by immunohistochemistry (IHC) (3+) by a validated approved method (Wolff et al, 2013) must be confirmed.
Participant milestones
| Measure |
Breast Cancer Participants Treated With Neratinib
Participants with stage 1 to 3c disease receiving extended adjuvant therapy are anticipated to participate in the study for approximately 1 year: 1 month for screening and 12 months of treatment, and 1 month of safety follow up.
Patients with mBC are anticipated to participate in the study for an average of 12 month: 1 month of screening, 9.5 months for treatment, and 1 month of safety follow up.
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|---|---|
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Overall Study
STARTED
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6
|
|
Overall Study
Treated
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib
Baseline characteristics by cohort
| Measure |
Neratinib
n=5 Participants
Overall Neratinib all arms
|
|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 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
|
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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 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
Portugal
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to second colonoscopy, which is 88 days after start of neratinib treatment.Population: Subjects who had a baseline colonoscopy and a second colonoscopy with findings to report.
The primary endpoint is to describe the changes in colon pathology between the baseline colonoscopy and the second colonoscopy.
Outcome measures
| Measure |
Neratinib Patients With 2 Colonoscopies
n=4 Participants
Subjects who had a baseline colonoscopy and a second colonoscopy with findings to report.
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|---|---|
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Changes in Colon Pathology
No Significant Findings
|
2 participants
|
|
Changes in Colon Pathology
Mild Changes
|
2 participants
|
SECONDARY outcome
Timeframe: From baseline to second colonoscopy, which is 88 days after start of neratinib treatment.Population: All treated patients
Incidence and severity of treatment emergent (TEAE) diarrhea will be summarized according to the NCI-CTCAE version 4.0 in the first cycle of neratinib treatment, which is from the time of the first colonoscopy to the second colonoscopy, or 28 days for subjects with only one colonoscopy. Incidence is defined as the number of patients experiencing diarrhea divided by the number of patients at risk.
Outcome measures
| Measure |
Neratinib Patients With 2 Colonoscopies
n=5 Participants
Subjects who had a baseline colonoscopy and a second colonoscopy with findings to report.
|
|---|---|
|
Incidence and Severity of Diarrhea
TEAE Diarrhea
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80 percentage of participants
|
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Incidence and Severity of Diarrhea
Serious Diarrhea
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0 percentage of participants
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Adverse Events
Safety
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety
n=5 participants at risk
Safety population (treated patients)
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
20.0%
1/5 • Number of events 1 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Number of events 1 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
20.0%
1/5 • Number of events 1 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Number of events 1 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
Other adverse events
| Measure |
Safety
n=5 participants at risk
Safety population (treated patients)
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
5/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Gastrointestinal disorders
Faeces hard
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Gastrointestinal disorders
Faeces soft
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Infections and infestations
Paronychia
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • From time of first dose, through 28 days after last dose, assessed up to 16 months.
Safety population: Participants receiving at least 1 dose of investigational product. Serious and Other Adverse Events were monitored/assessed only in the safety population
|
Additional Information
Senior Director, Clinical Operations
Puma Biotechnology, Inc.
Phone: 1-424-248-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place