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
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ClinicalTrials.gov Identifier: NCT02400476 |
Recruitment Status :
Completed
First Posted : March 27, 2015
Results First Posted : May 6, 2022
Last Update Posted : May 6, 2022
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Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | February 17, 2015 | ||||||||||||||||||
First Posted Date ICMJE | March 27, 2015 | ||||||||||||||||||
Results First Submitted Date ICMJE | February 28, 2022 | ||||||||||||||||||
Results First Posted Date ICMJE | May 6, 2022 | ||||||||||||||||||
Last Update Posted Date | May 6, 2022 | ||||||||||||||||||
Actual Study Start Date ICMJE | February 2015 | ||||||||||||||||||
Actual Primary Completion Date | April 22, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0. [ Time Frame: From first dose of investigational product through 28 days after last dose, up to 15.5 months. ] 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.
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Original Primary Outcome Measures ICMJE |
Incidence/Severity of diarrhea captured in the clinical study database [ Time Frame: Entire length of study (15 months) ] Review of the incidence and severity of diarrhea.
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | 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 | ||||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||||
Brief Summary | 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. | ||||||||||||||||||
Detailed Description | 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:
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Early Stage HER2+ Breast Cancer | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Barcenas CH, Hurvitz SA, Di Palma JA, Bose R, Chien AJ, Iannotti N, Marx G, Brufsky A, Litvak A, Ibrahim E, Alvarez RH, Ruiz-Borrego M, Chan N, Manalo Y, Kellum A, Trudeau M, Thirlwell M, Garcia Saenz J, Hunt D, Bryce R, McCulloch L, Rugo HS, Tripathy D, Chan A; CONTROL Study Investigators. Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial. Ann Oncol. 2020 Sep;31(9):1223-1230. doi: 10.1016/j.annonc.2020.05.012. Epub 2020 May 25. | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
563 | ||||||||||||||||||
Original Estimated Enrollment ICMJE |
70 | ||||||||||||||||||
Actual Study Completion Date ICMJE | April 22, 2021 | ||||||||||||||||||
Actual Primary Completion Date | April 22, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Australia, Austria, Canada, France, Germany, Spain, United States | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT02400476 | ||||||||||||||||||
Other Study ID Numbers ICMJE | PUMA-NER-6201 2015-004374-15 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Puma Biotechnology, Inc. | ||||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||||
Current Study Sponsor ICMJE | Puma Biotechnology, Inc. | ||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | Puma Biotechnology, Inc. | ||||||||||||||||||
Verification Date | January 2021 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |