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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

Primary Purpose

Early Stage HER2+ Breast Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Neratinib
Loperamide
Colestipol
Budesonide
Sponsored by
Puma Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage HER2+ Breast Cancer focused on measuring HER2 +, Breast Cancer, Neratinib, Nerlynx, Loperamide, Colestipol, Budesonide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18; male or female
  • Early breast cancer (stage I-3c)
  • Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+
  • Prior course of adjuvant trastuzumab given >2 weeks and ≤1 year from enrollment
  • No evidence of local/regional recurrence or metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Male patients with female partners of childbearing potential must agree and commit to use a condom and women of childbearing potential must not be pregnant and must agree and commit to the use of a highly effective non-hormonal method of contraception
  • Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or ECHO

Exclusion Criteria:

  • Major surgery < 30 days
  • Chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) < 14 days
  • Corrected QT Interval (QTc) >0.450 seconds (males) or >0.470 (females) or other active cardiac disease
  • Significant chronic GI disorder with diarrhea as a major symptom
  • Active, unresolved infections
  • Currently pregnant or breast-feeding

Sites / Locations

  • Alabama Oncology
  • Compassionate Care Research Group Inc.
  • St. Joseph Heritage Healthcare
  • Ronald Reagan UCLA Medical Center
  • Emad Ibrahim, M.D., Inc.
  • Torrance Memorial Physician Network Cancer Care Associates
  • Compassionate Care Research Group Inc.
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • The Oncology Institute of Hope and Innovation
  • Cancer Center of Santa Barbara with Sansum Clinic
  • Central Coast Medical Oncology Corporation
  • Memorial Healthcare System
  • Florida Cancer Research Institute, LLC
  • Hematology-Oncology Associates of the Treasure Coast
  • Baptist Health Urgent Care Sawgrass
  • Cancer Treatment Centers of America
  • Decatur Memorial Hospital Cancer Care Specialists of Central Illinois
  • Ingalls Memorial Hospital
  • Norton Cancer Institute
  • Central Maine Medical Center
  • University of Maryland, Greenebaum Comprehensive Cancer Center
  • North Mississippi Medical Center Hematology and Oncology Services
  • Washington University School of Medicine
  • Great Plains Health (Callahan Cancer Center)
  • Saint Barnabas Medical Center
  • Jersey Shore University Medical Center
  • Rutgers Cancer Institute of New Jersey
  • MD Anderson Cancer Center at Cooper
  • Clinical Research Alliance, Inc
  • Good Samaritan Hospital Samaritan Pastega Regional Cancer Center
  • Providence Portland Medical Center
  • Magee-Womens Hospital of UPMC
  • Charleston Hematology Oncology Associates
  • Saint Joseph / Candler SC Cancer Specialists
  • Coastal Bend Cancer Center
  • The University of Texas MD Anderson Cancer Center
  • Community Cancer Trials of Utah
  • Utah Cancer Specialists
  • Inova Schar Cancer Institute
  • Sydney Adventist Hospital
  • Ashford Cancer Centre Research
  • BCRC-WA, Hollywood Private Hospital
  • Univ. Klinik für Innere Medizin, Klin. Abt. Onkologie
  • Medical University of Innsbruck-Department of Gynecology
  • Uniklinikum Salzburg, Landeskrankenhaus, Univ. Klinik fur Innere Medizin III der PMU
  • Medical University of Vienna, Department of Oncology
  • Medical University of Vienna,Department of Obstetrics and Gynecology
  • Sunnybrook Research Insitute
  • McGill University Health Centre, Cedars Cancer Centre
  • CHU Group Hospitalier Pitié-Salpêtrière, Service d'oncologie Médicale
  • Institut Gustave Roussy
  • Praxis für interdisziplinäre Onkologie & Hämatologie
  • Mammazentrum HH am Krankenhaus Jerusalem
  • Universitaetsklinikum Schleswig-Holstein
  • Universitaetsklinikum Schleswig-Holstein (UKSH), Klinik fuer Gynaekologie und Geburtshilfe, Studienzentrale Gynäkologische Onkologie (SGC) Kiel
  • Sana Klinikum Offenbach GmbH - Frauenklinik
  • Hospital Clinico San Carlos
  • Hospital Universitario Virgen del Rocio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Loperamide

Budesonide and Loperamide

Colestipol and Loperamide

Colestipol with Loperamide as needed

Neratinib Dose Escalation 1

Neratinib Dose Escalation 2

Arm Description

240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed.

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.

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.

240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 17, 2015
Last Updated
April 12, 2022
Sponsor
Puma Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02400476
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
April 22, 2021 (Actual)
Study Completion Date
April 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Puma Biotechnology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Neratinib 240 mg orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Amendment 3, an anti-inflammatory treatment for one cycle and loperamide to be administered daily for two 28-day cycles and then as needed. Closed to enrollment. Amendment 4, colestipol for one cycle and loperamide to be administered one cycle and then as needed. Closed to enrollment. Amendment 5, colestipol for one cycle and loperamide as needed. Closed to enrollment. Amendment 6/6.1, 120 mg neratinib for Week 1 (C1D1-C1D7), followed by 160 mg neratinib for Week 2 (C1D8-C1D14), followed by 240 mg neratinib for Week 3 and thereafter (C1D15 to end of treatment). Loperamide as needed. Closed to enrollment. Amendment 7/7.1, 160 mg neratinib for the first 2 weeks (C1D1 - C1D14), followed by 200 mg neratinib for the next 2 weeks (C1D15 - C1D28), followed by 240 mg neratinib thereafter (C2D1 to end of treatment). Loperamide as needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage HER2+ Breast Cancer
Keywords
HER2 +, Breast Cancer, Neratinib, Nerlynx, Loperamide, Colestipol, Budesonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
563 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loperamide
Arm Type
Experimental
Arm Description
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed.
Arm Title
Budesonide and Loperamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Colestipol and Loperamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Colestipol with Loperamide as needed
Arm Type
Experimental
Arm Description
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed.
Arm Title
Neratinib Dose Escalation 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Neratinib Dose Escalation 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Neratinib
Other Intervention Name(s)
Nerlynx
Intervention Type
Drug
Intervention Name(s)
Loperamide
Intervention Type
Drug
Intervention Name(s)
Colestipol
Intervention Description
2 g twice daily with or without food for one 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
9 mg extended release tablets once daily with or without food for 28 days
Primary Outcome Measure Information:
Title
Percentage of Patients With Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0.
Description
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.
Secondary Outcome Measure Information:
Title
Percentage of Patients With Diarrhea by Grade, According to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), Version 4.0.
Description
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.
Title
Percentage of Patients With Serious Adverse Events and Other Adverse Events of Special Interest
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18; male or female Early breast cancer (stage I-3c) Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+ Prior course of adjuvant trastuzumab given >2 weeks and ≤1 year from enrollment No evidence of local/regional recurrence or metastatic disease Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 Male patients with female partners of childbearing potential must agree and commit to use a condom and women of childbearing potential must not be pregnant and must agree and commit to the use of a highly effective non-hormonal method of contraception Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or ECHO Exclusion Criteria: Major surgery < 30 days Chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) < 14 days Corrected QT Interval (QTc) >0.450 seconds (males) or >0.470 (females) or other active cardiac disease Significant chronic GI disorder with diarrhea as a major symptom Active, unresolved infections Currently pregnant or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Scientific Officer
Organizational Affiliation
Puma Biotechnology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Compassionate Care Research Group Inc.
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Emad Ibrahim, M.D., Inc.
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Torrance Memorial Physician Network Cancer Care Associates
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Compassionate Care Research Group Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Cancer Center of Santa Barbara with Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Florida Cancer Research Institute, LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Hematology-Oncology Associates of the Treasure Coast
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Baptist Health Urgent Care Sawgrass
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Facility Name
Cancer Treatment Centers of America
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Specialists of Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Central Maine Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
University of Maryland, Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
North Mississippi Medical Center Hematology and Oncology Services
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Great Plains Health (Callahan Cancer Center)
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
MD Anderson Cancer Center at Cooper
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
Clinical Research Alliance, Inc
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Good Samaritan Hospital Samaritan Pastega Regional Cancer Center
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Charleston Hematology Oncology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Saint Joseph / Candler SC Cancer Specialists
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
Coastal Bend Cancer Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Community Cancer Trials of Utah
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
Country
Australia
Facility Name
Ashford Cancer Centre Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
BCRC-WA, Hollywood Private Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Univ. Klinik für Innere Medizin, Klin. Abt. Onkologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medical University of Innsbruck-Department of Gynecology
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Uniklinikum Salzburg, Landeskrankenhaus, Univ. Klinik fur Innere Medizin III der PMU
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Medical University of Vienna, Department of Oncology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medical University of Vienna,Department of Obstetrics and Gynecology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Sunnybrook Research Insitute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
McGill University Health Centre, Cedars Cancer Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHU Group Hospitalier Pitié-Salpêtrière, Service d'oncologie Médicale
City
Paris
ZIP/Postal Code
5013
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Praxis für interdisziplinäre Onkologie & Hämatologie
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
Facility Name
Mammazentrum HH am Krankenhaus Jerusalem
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein (UKSH), Klinik fuer Gynaekologie und Geburtshilfe, Studienzentrale Gynäkologische Onkologie (SGC) Kiel
City
Kiel
ZIP/Postal Code
D-24106
Country
Germany
Facility Name
Sana Klinikum Offenbach GmbH - Frauenklinik
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
IPD Sharing Access Criteria
Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest. Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
IPD Sharing URL
https://www.pumabiotechnology.com/data_sharing_policy.html
Citations:
PubMed Identifier
32464281
Citation
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.
Results Reference
derived

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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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