60 and older, any sex, with HER2 Positive Breast Carcinoma or Stage IV Breast Cancer AJCC v6 and v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent of Participants With Grade 2 or Higher ToxicitiesPrimary· On treatment, 28 days per cycle up to 1 year
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Tables will be created to summarize the toxicities and side effects by organ system, attribution and severity for all participants that receive at least one dose of neratinib. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 2 or higher toxicities attributed to neratinib.
Group
Value
95% CI
Treatment (Neratinib)
80
59 – 93
Count of Participants With Grade 3 or Higher Gastrointestinal (GI) Toxicities Such as Diarrhea, Nausea and VomitingSecondary· On treatment, 28 days per cycle up to 1 year
Will be graded according to the NCI CTCAE version 4.0. Tables will be created to summarize the toxicities and side effects by organ system, attribution and severity for all participants that receive at least one dose of neratinib.
Diarrhea
Group
Value
95% CI
Treatment (Neratinib)
5
Vomiting
Group
Value
95% CI
Treatment (Neratinib)
2
Abdominal pain
Group
Value
95% CI
Treatment (Neratinib)
2
Nausea
Group
Value
95% CI
Treatment (Neratinib)
1
Rate of Participants With a Dose ReductionSecondary· On treatment, up to 48 months
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
Group
Value
95% CI
Treatment (Neratinib)
36
18 – 57
Rate of Participants Requiring HospitalizationsSecondary· On treatment, up to 48 months
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for hospitalizations.
Group
Value
95% CI
Treatment (Neratinib)
16
5 – 36
Tumor Response Using Response Evaluation Criteria in Solid Tumors (RECIST)Secondary· Participants are evaluated every 12 weeks, up to 48 months
Complete Response (CR): Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis.
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions.
Stable Disease (S
Group
Value
95% CI
Treatment (Neratinib)
1
Treatment (Neratinib)
11
Treatment (Neratinib)
12
Treatment (Neratinib)
1
Median Progression-free Survival (PFS) in MonthsSecondary· From the date treatment begins until the first date on which recurrence, progression or death due to any cause, assessed up to 48 months
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for PFS. PFS will be estimated using the product limit method of Kaplan and Meier.
Group
Value
95% CI
Treatment (Neratinib)
2.6
2.56 – 5.26
Median Overall Survival (OS)Secondary· Time from start of treatment to death due to any cause, assessed up to 48 months
OS will be estimated using the product limit method of Kaplan and Meier.
Group
Value
95% CI
Treatment (Neratinib)
17.4
10.3 – NA
Cancer-specific Geriatric Assessment ScoreSecondary· At day 0 of treatment
The cancer specific geriatric assessment score includes an evaluation of functional status, co-morbidity, cognition, psychological stats, social functioning and support, and nutritional status. It assesses a patient's age, gender, height, weight, cancer type, dosage, number of chemotherapy agents, hemoglobin, hearing, number of falls in past 6 months, able to take own medicine, whether walking is limited, have physical or emotional problems interfered with social activities and serum creatinine.
Scores can range from 0 to to 1, with a higher score indicating higher risk of chemotherapy toxici
Group
Value
95% CI
Treatment (Neratinib)
0.34
0.19 – 0.59
Pharmacokinetics of Steady State Neratinib Concentration Transformed Using a Logarithm Base 2Secondary· Day 0 to day 15
Least squares regression was used to assess the relationship between steady state neratinib concentration, transformed using a logarithm base 2 transformation, and age
Group
Value
95% CI
Treatment (Neratinib)
4.7
± 1.09
Adverse events — posted to ClinicalTrials.gov
Time frame: Through study completion, an average of 18 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies the side effects of and how well neratinib works in treating older patients with stage IV HER2-positive breast cancer. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 18 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02673398.