A Phase 2 interventional study of Neratinib and Loperamide in Early Stage HER2+ Breast Cancer, sponsored by Puma Biotechnology, Inc.. Completed at 58 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Puma Biotechnology, Inc. · Phase 2, Interventional, and Treatment
Among 39 studies testing neratinib in Breast Neoplasms — 7 open to participants now, 9 under way, 1 of them phase 3. neratinib · Breast Neoplasms.
Among the 39 studies testing neratinib in Breast Neoplasms, this one is the 5th largest by enrollment, is the only one that started in 2015, is one of 23 in phase 2, and was the 20th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 563 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →7 of the 39 studies testing neratinib in Breast Neoplasms are open now, in 3 countries. Each count lists the studies.
neratinib: first FDA approval 2017 (NERLYNX), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →39 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2015.
Median enrollment 60 across the 39 interventional studies. Of the 26 that completed or were terminated, 21 (81%) have results posted.
15 of 39 have an industry lead sponsor. The 10 most frequent:
Puma Biotechnology, Inc. is the lead sponsor of 38 studies on the registry; 3 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
16 studies in Breast Neoplasms by Puma Biotechnology, Inc.: 1 open now, 1 under way, none of them phase 3. Of 15 finished, 13 (87%) have results posted.
Among the 16 studies in Breast Neoplasms by Puma Biotechnology, Inc., this one is the 3rd largest by enrollment, is the only one that started in 2015, is one of 6 in phase 2, and was the 14th registered.
Puma Biotechnology, Inc.’s Breast Neoplasms studies by the year they started, since 2003.
3 of the studies testing neratinib in Breast Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04886531Ruth O'ReganTrial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers | 2026-12-22 |
| NCT06008275Baylor Research InstituteNeratinib in Combination With Ruxolitinib in Patients With mTNBC | 2027-06 |
| NCT05388149University Health Network, TorontoKadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease | 2027-07 |
Among the 39 studies testing neratinib in Breast Neoplasms, from their registry updates:
Among Puma Biotechnology, Inc.’s 16 in Breast Neoplasms:
Nothing recorded among them since 2026-09-25.
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.
This is an open-label, Phase 2 study that will investigate the incidence and severity of diarrhea in early-stage HER2+ breast cancer patients receiving neratinib with loperamide, alone and in combination with an anti-inflammatory treatment or a bile acid sequestrant treatment, or neratinib dose escalation, who have previously undergone a course of trastuzumab therapy in the adjuvant setting.
Patients will receive:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed.
Drug: Neratinib · Drug: Loperamide
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter.
Drug: Neratinib · Drug: Loperamide · Drug: Budesonide
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter.
Drug: Neratinib · Drug: Loperamide · Drug: Colestipol
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed.
Drug: Neratinib · Drug: Loperamide · Drug: Colestipol
120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed.
Drug: Neratinib · Drug: Loperamide
160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only.
Drug: Neratinib · Drug: Loperamide
Also known as: Nerlynx
2 g twice daily with or without food for one 28 day cycle
9 mg extended release tablets once daily with or without food for 28 days
Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0.
The primary objective of this study is to characterize the percentage of patients with Grade 3 or higher diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. Grade 3: Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.
Time frame: From first dose of investigational product through 28 days after last dose, up to 15.5 months.
Percentage of Patients With Diarrhea by Grade, According to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), Version 4.0.
Assess the percentage of patients with diarrhea after the administration of an anti-inflammatory agent, a bile acid sequestrant, or following two different dose-escalation regimens of neratinib, by maximum CTC grade. Grade 1: an increase of \<4 stools per day over baseline; mild increase in ostomy output compared to baseline. Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline. Grade 3: Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.
Time frame: From first dose of investigational product through 28 days after last dose, up to 15.5 months.
Percentage of Patients With Serious Adverse Events and Other Adverse Events of Special Interest
Assess the percentage of patients with serious adverse events (SAEs) and other adverse events of special interest (AESI). AESIs were selected based on the known safety profile of neratinib as well as typical key body system toxicity concerns generally reviewed for any new drug. These AESIs were grouped into the following categories: gastrointestinal toxicity (diarrhea and stomatitis), hepatotoxicity, pulmonary toxicity (interstitial lung disease), cardiac toxicity (LVEF decreased), and dermatologic toxicity (rash and nail disorders). The AESIs were analyzed by searching the clinical database for all TEAEs and SAEs using either Standardized MedDRA Queries (SMQs) or, if an applicable SMQ did not exist, a Sponsor-defined list of MedDRA preferred terms.
Time frame: From first dose of investigational product through 28 days after last dose, up to 15.5 months.
| Milestone | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 |
|---|---|---|---|---|---|---|
| Started | 137 | 64 | 136 | 104 | 60 | 62 |
| Completed | 76 | 52 | 95 | 74 | 45 | 46 |
| Not completed | 61 | 12 | 41 | 30 | 15 | 16 |
| Withdrew: Adverse event | 57 | 10 | 22 | 19 | 5 | 8 |
| Withdrew: Withdrawal by subject | 4 | 1 | 12 | 7 | 5 | 5 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 3 | 1 |
| Withdrew: Physician decision | 0 | 0 | 1 | 1 | 0 | 1 |
| Withdrew: Other, disease progression | 0 | 1 | 2 | 1 | 2 | 1 |
| Withdrew: Other, decreased quality of life | 0 | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Other, noncompliance to protocol requirements | 0 | 0 | 2 | 1 | 0 | 0 |
The primary objective of this study is to characterize the percentage of patients with Grade 3 or higher diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. Grade 3: Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.
| Percentage of participants | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 |
|---|---|---|---|---|---|---|
| Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0. | 30.7 (23.1 to 39.1) | 28.1 (17.6 to 40.8) | 20.6 (14.1 to 28.4) | 32.7 (23.8 to 42.6) | 13.3 (5.9 to 24.6) | 27.4 (16.9 to 40.2) |
Assess the percentage of patients with diarrhea after the administration of an anti-inflammatory agent, a bile acid sequestrant, or following two different dose-escalation regimens of neratinib, by maximum CTC grade. Grade 1: an increase of \<4 stools per day over baseline; mild increase in ostomy output compared to baseline. Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline. Grade 3: Increase of \>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.
| Percentage of participants | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 |
|---|---|---|---|---|---|---|
| Percentage of Patients w Grade 1 Diarrhea | 24.1 | 23.4 | 27.9 | 32.7 | 40.0 | 37.1 |
| Percentage of Patients w Grade 2 Diarrhea | 24.8 | 34.4 | 34.6 | 29.8 | 45.0 | 33.9 |
| Percentage of Patients w Grade 3 Diarrhea | 30.7 | 28.1 | 20.6 | 32.7 | 13.3 | 27.4 |
Assess the percentage of patients with serious adverse events (SAEs) and other adverse events of special interest (AESI). AESIs were selected based on the known safety profile of neratinib as well as typical key body system toxicity concerns generally reviewed for any new drug. These AESIs were grouped into the following categories: gastrointestinal toxicity (diarrhea and stomatitis), hepatotoxicity, pulmonary toxicity (interstitial lung disease), cardiac toxicity (LVEF decreased), and dermatologic toxicity (rash and nail disorders). The AESIs were analyzed by searching the clinical database for all TEAEs and SAEs using either Standardized MedDRA Queries (SMQs) or, if an applicable SMQ did not exist, a Sponsor-defined list of MedDRA preferred terms.
| percentage of participants | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 |
|---|---|---|---|---|---|---|
| Percentage of Patients with SAEs | 6.57 | 6.25 | 6.62 | 2.88 | 8.33 | 8.06 |
| Percentage of Patients with AESI-Gastrointestinal Toxicities (Diarrhoea and Stomatitis Broad Search) | 81.75 | 87.5 | 83.82 | 96.15 | 98.33 | 98.39 |
| Percentage of Patients with-Hepatotoxicities SMQ (Broad Search) | 12.41 | 7.81 | 4.41 | 4.81 | 8.33 | 4.84 |
| Percentage of Patients with AESI- Interstitial Lung Disease SMQ (Broad Search) | 0 | 0 | 0 | 0 | 0 | 0 |
| Percentage of Patients with AESI-Cardiac Toxicities SMQ (Broad Search) | 5.84 | 6.25 | 10.29 | 7.69 | 10.00 | 4.84 |
| Percentage of Patients with AESI - Dermatologic Toxicities (Rash and Nail Disorders) | 12.41 | 37.50 | 23.53 | 18.27 | 11.67 | 30.65 |
| Percentage of Patients with AESI-Gastrointestinal Toxicities (Narrow Search) | 80.29 | 85.94 | 83.09 | 95.19 | 98.33 | 98.39 |
| Percentage of Patients with AESI-Hepatotoxicities SMQ (Narrow Search) | 10.95 | 7.81 | 3.68 | 3.85 | 8.33 | 4.84 |
| Percentage of Patients with AESI- Interstitial Lung Disease SMQ (Narrow Search) | 0 | 0 | 0 | 0 | 0 | 0 |
| Percentage of Patients with AESI-Cardiac Toxicities SMQ (Narrow Search) | 2.92 | 0 | 1.47 | 0.96 | 1.67 | 0 |
Collected over From time of first dose, through 28 days after last dose, assessed up to 15.5 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Loperamide | 0/137 (0%) | 9/137 (6.6%) | 137/137 (100%) |
| Budesonide and Loperamide | 0/64 (0%) | 4/64 (6.3%) | 64/64 (100%) |
| Colestipol and Loperamide | 0/136 (0%) | 9/136 (6.6%) | 136/136 (100%) |
| Colestipol With Loperamide as Needed | 0/104 (0%) | 3/104 (2.9%) | 104/104 (100%) |
| Neratinib Dose Escalation 1 | 0/60 (0%) | 5/60 (8.3%) | 60/60 (100%) |
| Neratinib Dose Escalation 2 | 0/62 (0%) | 5/62 (8.1%) | 62/62 (100%) |
| Event | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 |
|---|---|---|---|---|---|---|
| Retinal detachmentEye disorders | 0/137 | 0/64 | 0/136 | 0/104 | 1/60 | 0/62 |
| Fat necrosisGeneral disorders | 0/137 | 0/64 | 0/136 | 0/104 | 1/60 | 0/62 |
| BacteraemiaInfections and infestations | 0/137 | 0/64 | 0/136 | 0/104 | 1/60 | 0/62 |
| Lower respiratory tract infectionInfections and infestations | 0/137 | 0/64 | 0/136 | 0/104 | 1/60 | 0/62 |
| Electrocardiogram QT prolongedInvestigations | 0/137 | 0/64 | 0/136 | 0/104 | 1/60 | 0/62 |
| DehydrationMetabolism and nutrition disorders | 1/137 | 0/64 | 1/136 | 1/104 | 1/60 | 0/62 |
| SeizureNervous system disorders | 1/137 | 0/64 | 0/136 | 0/104 | 1/60 | 0/62 |
| SyncopeNervous system disorders | 0/137 | 0/64 | 2/136 | 0/104 | 1/60 | 0/62 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/137 | 0/64 | 0/136 | 0/104 | 1/60 | 0/62 |
| PancreatitisGastrointestinal disorders | 0/137 | 0/64 | 0/136 | 0/104 | 0/60 | 1/62 |
| Event | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 |
|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 109/137 | 55/64 | 113/136 | 99/104 | 59/60 | 61/62 |
| ConstipationGastrointestinal disorders | 78/137 | 48/64 | 93/136 | 39/104 | 22/60 | 15/62 |
| NauseaGastrointestinal disorders | 78/137 | 32/64 | 83/136 | 64/104 | 27/60 | 28/62 |
| FatigueGeneral disorders | 73/137 | 34/64 | 65/136 | 41/104 | 28/60 | 19/62 |
| VomitingGastrointestinal disorders | 36/137 | 16/64 | 43/136 | 25/104 | 9/60 | 5/62 |
| Abdominal painGastrointestinal disorders | 36/137 | 12/64 | 26/136 | 27/104 | 13/60 | 15/62 |
| Decreased appetiteMetabolism and nutrition disorders | 26/137 | 11/64 | 24/136 | 26/104 | 8/60 | 8/62 |
| HeadacheNervous system disorders | 26/137 | 12/64 | 20/136 | 24/104 | 13/60 | 8/62 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 10/137 | 14/64 | 15/136 | 13/104 | 9/60 | 4/62 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 15/137 | 8/64 | 14/136 | 15/104 | 12/60 | 8/62 |
| Age, Categorical(Participants) | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 116 | 58 | 117 | 93 | 51 | 52 | 487 |
| >=65 years | 21 | 6 | 19 | 11 | 9 | 10 | 76 |
| Age, Continuous(years) | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 53.39 ± 11.06 | 49.11 ± 10.55 | 52.49 ± 11.08 | 51.94 ± 10.23 | 51.90 ± 10.71 | 53.82 ± 10.15 | 52.31 ± 10.76 |
| Sex: Female, Male(Participants) | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 | Total |
|---|---|---|---|---|---|---|---|
| Female | 137 | 64 | 133 | 104 | 60 | 62 | 560 |
| Male | 0 | 0 | 3 | 0 | 0 | 0 | 3 |
| Race/Ethnicity, Customized(Participants) | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 | Total |
|---|---|---|---|---|---|---|---|
| Race — White | 113 | 50 | 96 | 80 | 53 | 52 | 444 |
| Race — Black or African American | 11 | 5 | 9 | 8 | 1 | 2 | 36 |
| Race — Asian | 8 | 4 | 13 | 9 | 3 | 1 | 38 |
| Race — American Indian or Alaska Native | 1 | 0 | 1 | 0 | 0 | 0 | 2 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 1 | 3 | 0 | 0 | 0 | 4 |
| Race — Other | 3 | 2 | 9 | 0 | 1 | 3 | 18 |
| Race — Unknown | 0 | 1 | 2 | 1 | 0 | 1 | 5 |
| Race — Missing | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Race — Not Reported | 1 | 1 | 3 | 6 | 2 | 2 | 15 |
| Region of Enrollment(participants) | Loperamide | Budesonide and Loperamide | Colestipol and Loperamide | Colestipol With Loperamide as Needed | Neratinib Dose Escalation 1 | Neratinib Dose Escalation 2 | Total |
|---|---|---|---|---|---|---|---|
| Canada | 0 | 0 | 4 | 10 | 6 | 7 | 27 |
| Austria | 0 | 0 | 0 | 0 | 0 | 4 | 4 |
| United States | 132 | 52 | 115 | 83 | 20 | 11 | 413 |
| Australia | 5 | 12 | 17 | 11 | 23 | 18 | 86 |
| France | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| Germany | 0 | 0 | 0 | 0 | 0 | 2 | 2 |
| Spain | 0 | 0 | 0 | 0 | 11 | 14 | 25 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge. In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings. Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information. Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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Studies of the drugs tested here: Neratinib · Loperamide