Basket Study of Neratinib in Participants With Solid Tumo... | NCT01953926 | Trialant
NCT01953926
Sponsor
Puma Biotechnology, Inc.
Status
Terminated
Last Update Posted
Mar 12, 2024Actual
Enrollment
582Actual
Phase
Phase 2
Conditions
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Interventions
Neratinib
Fulvestrant
Trastuzumab
Paclitaxel
Countries
United States
Australia
Belgium
Canada
Denmark
France
Ireland
Israel
Italy
Serbia
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01953926
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PUMA-NER-5201
Secondary IDs
ID
Type
Description
Link
2013-002872-42
EudraCT Number
Brief Title
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Official Title
An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
Acronym
SUMMIT
Organization
Puma Biotechnology, Inc.INDUSTRY
Status Module
Record Verification Date
Feb 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated to align with the sponsor's current development plans for neratinib. The decision was not based on any new efficacy or safety data for neratinib.
Expanded Access Info
No
Start Date
Sep 30, 2013Actual
Primary Completion Date
Jan 2, 2023Actual
Completion Date
Jan 2, 2023Actual
First Submitted Date
Sep 26, 2013
First Submission Date that Met QC Criteria
Sep 26, 2013
First Posted Date
Oct 1, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 21, 2023
Results First Submitted that Met QC Criteria
Feb 12, 2024
Results First Posted Date
Mar 12, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 12, 2024
Last Update Posted Date
Mar 12, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Puma Biotechnology, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.
Detailed Description
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. The study has a basket design and includes several cohorts, either defined by an actionable somatic mutation or by actionable mutation and tumor histology, including HER2 mutant breast, HER2 mutant cervical, HER2 mutant salivary gland, and EGFR Exon 18 mutant Non-small cell lung cancers.
The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period.
Conditions Module
Conditions
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Keywords
Neratinib
Nerlynx
Breast
Solid Tumors
Cancer
HER2 mutations
EGFR mutations
Fulvestrant
Trastuzumab
Cervical
Salivary
ERBB2
Exon 18
Metastatic
HR Positive
Lung
Non-Small Cell Lung Cancer (NSCLC)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
582Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Neratinib monotherapy
Experimental
Neratinib monotherapy in HER2 mutated cancers including cervical, salivary gland, and lung cancers containing EGFR exon 18 mutations.
Cohorts closed to enrollment in prior amendments: HER2 mutant cancers including bladder/urinary, colorectal, endometrial, breast HR-positive, TNBC HR-negative, lung, gastroesophageal, biliary, and ovarian; HER3 mutant solid tumor NOS; HER4 mutant solid tumor NOS; fibrolamellar carcinoma and EGFR brain.
Drug: Neratinib
Neratinib and Trastuzumab
Experimental
Neratinib and Trastuzumab in HER2 mutated (TNBC, HR-negative) breast cancers.
Cohorts closed to enrollment in in prior amendments: colorectal, lung cancer HER2 mutant.
Drug: Neratinib
Drug: Trastuzumab
Neratinib, Fulvestrant and Trastuzumab (Randomized)
Experimental
Neratinib, Fulvestrant and Trastuzumab or Fulvestrant and Trastuzumab or Fulvestrant alone in HER2 mutated (HR-positive with prior CDK4/6i) breast cancers.
Drug: Neratinib
Drug: Fulvestrant
Drug: Trastuzumab
Neratinib, Fulvestrant and Trastuzumab (Non-Randomized)
Experimental
Neratinib, Fulvestrant and Trastuzumab in HER2 mutated (HR-positive with or without CDK4/6i) breast cancers.
Drug: Neratinib
Drug: Fulvestrant
Drug: Trastuzumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Neratinib
Drug
240 mg administered orally, once daily with food, continuously in 28 day cycles
Neratinib and Fulvestrant
Neratinib and Paclitaxel
Neratinib and Trastuzumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Percentage of participants who are confirmed by independent central review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts).
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort)
Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (cervical cancer cohort).
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts)
Percentage of participants who achieve CR or PR per Response Evaluation Criteria in Sold Tumors Criteria (RECIST) v1.1, or other defined response criteria, at the first scheduled tumor assessment (all other cohorts), per RECIST (if assessed) or PERCIST.
RECISTv1.1 for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
PERCISTv1.0: Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels
Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions.
Positive Metabolic Response - Participants having either "Complete Metabolic Response" or "Part
Secondary Outcomes
Measure
Description
Time Frame
Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort)
Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts).
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent
Histologically confirmed cancers for which no curative therapy exists
Documented HER2 or EGFR exon 18 mutation
Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol
At least one measurable lesion, defined by RECIST v1.1
Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible
Participants who are receiving any other anticancer agents
Symptomatic or unstable brain metastases
Women who are pregnant or breast-feeding
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
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.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 3, 2021
Dec 21, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Finland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Neratinib and Paclitaxel
Experimental
Neratinib and Paclitaxel in HER2 mutated bladder/urinary tract cancers.
Drug: Neratinib
Drug: Paclitaxel
Neratinib and Fulvestrant
Experimental
Neratinib and Fulvestrant in HER2 mutated (HR-positive) breast cancers.
Drug: Neratinib
Drug: Fulvestrant
Neratinib monotherapy
Neratinib, Fulvestrant and Trastuzumab (Non-Randomized)
Neratinib, Fulvestrant and Trastuzumab (Randomized)
Nerlynx
Fulvestrant
Drug
500 mg administered as two 5 mL injections on Days 1, 15, and 29; then once every 4 weeks thereafter month, then Day 1 of every 4 week cycle
Neratinib and Fulvestrant
Neratinib, Fulvestrant and Trastuzumab (Non-Randomized)
Neratinib, Fulvestrant and Trastuzumab (Randomized)
Faslodex
Trastuzumab
Drug
Initial dose of 8 mg/kg of trastuzumab administered IV on Day 1, followed by 6 mg/kg IV once every 3 weeks thereafter
Neratinib and Trastuzumab
Neratinib, Fulvestrant and Trastuzumab (Non-Randomized)
Neratinib, Fulvestrant and Trastuzumab (Randomized)
Herceptin
Paclitaxel
Drug
80mg/m^2 administered IV on Days 1, 8, and 15 of every 4 week cycle
Neratinib and Paclitaxel
Taxol
From first treatment date to first Complete or Partial Response, whichever came earlier, assessed up to 8 or 9 weeks
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts)
Percentage of participants who achieve CR or PR per RECIST v1.1, or metabolic complete response via PERCIST v1.0.
For RECIST, A complete or partial response that is confirmed no less than 4-weeks after the criteria for response are initially met. PERCIST criteria were used for patients without RECIST assessments.
From first treatment date to confirmed Complete or Partial Response, assessed up to 58 months.
Duration of Response (DOR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
From first response to first disease progression or death, assessed up to 58 months
Duration of Response (DOR) by Investigator Review (All Cohorts)
Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
From first response to first disease progression or death, assessed up to 58 months
Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Percentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment.
From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months
Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts)
Percentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment.
From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months
Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
Progression-Free Survival (PFS) by Investigator Review (All Cohorts)
Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
Number of Participants With Treatment-Emergent Adverse Events
The safety of neratinib in patients as measured by the incidence of treatment-emergent adverse events (TEAE), including serious adverse events (SAEs), in study participants. TEAEs are any adverse event that occurred on or after first dose of investigational product and up to 28 days after the last dose
From first dose through 28 days after the last dose, assessed up to 75 months.
Phoenix
Arizona
85054
United States
City of Hope
Duarte
California
91010
United States
University of California, San Diego
La Jolla
California
92093
United States
University of Southern California
Los Angeles
California
90089
United States
University of California, Los Angeles
Los Angeles
California
90095
United States
Stanford Cancer Center
Palo Alto
California
94304
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco
California
94115
United States
Kaiser Permanente NoCal (STRATA)
Vallejo
California
94589
United States
Mayo Clinic Florida
Jacksonville
Florida
32224
United States
University of Miami
Miami
Florida
33136
United States
Winship Cancer Institute, Emory University
Atlanta
Georgia
30322
United States
Northwestern University
Chicago
Illinois
60611
United States
Ochsner Clinic Foundation
New Orleans
Louisiana
70121
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park
Minnesota
55416
United States
Washington University
St Louis
Missouri
63110
United States
Roswell Park Comprehensive Cancer Center
Buffalo
New York
14263
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10065
United States
UPMC Magee-Woman's Hospital, Women's Cancer Center
Yonsei University Health System, Serverance Hospital
Seodaemun-Gu
Seoul
120-752
South Korea
Hospital Universitario Quiron Dexeus
Barcelona
08028
Spain
Hospital Universitario Vall d'Hebron
Barcelona
08035
Spain
Hospital Universitari Clinic Barcelona
Barcelona
08036
Spain
Hospital Clinico Universitario San Carlos
Madrid
28040
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid
28040
Spain
Hospital Universitario Madrid Sanchinarro (START Madrid)
Madrid
28050
Spain
Hospital Universitario Quiron Madrid
Madrid
28223
Spain
Instituto Valenciano de Oncologia
Valencia
46009
Spain
Hospital Clinico Universitario de Valencia
Valencia
46010
Spain
Royal Free Hospital
London
NW3 2QG
United Kingdom
Background
Smyth LM, Piha-Paul SA, Won HH, Schram AM, Saura C, Loi S, Lu J, Shapiro GI, Juric D, Mayer IA, Arteaga CL, de la Fuente MI, Brufksy AM, Spanggaard I, Mau-Sorensen M, Arnedos M, Moreno V, Boni V, Sohn J, Schwartzberg LS, Gonzalez-Farre X, Cervantes A, Bidard FC, Gorelick AN, Lanman RB, Nagy RJ, Ulaner GA, Chandarlapaty S, Jhaveri K, Gavrila EI, Zimel C, Selcuklu SD, Melcer M, Samoila A, Cai Y, Scaltriti M, Mann G, Xu F, Eli LD, Dujka M, Lalani AS, Bryce R, Baselga J, Taylor BS, Solit DB, Meric-Bernstam F, Hyman DM. Efficacy and Determinants of Response to HER Kinase Inhibition in HER2-Mutant Metastatic Breast Cancer. Cancer Discov. 2020 Feb;10(2):198-213. doi: 10.1158/2159-8290.CD-19-0966. Epub 2019 Dec 5.
Friedman CF, D'Souza A, Bello Roufai D, Tinker AV, de Miguel M, Gambardella V, Goldman J, Loi S, Melisko ME, Oaknin A, Spanggaard I, Shapiro GI, ElNaggar AC, Panni S, Ravichandran V, Frazier AL, DiPrimeo D, Eli LD, Solit DB. Targeting HER2-mutant metastatic cervical cancer with neratinib: Final results from the phase 2 SUMMIT basket trial. Gynecol Oncol. 2024 Feb;181:162-169. doi: 10.1016/j.ygyno.2023.12.004. Epub 2024 Jan 11.
Jhaveri K, Eli LD, Wildiers H, Hurvitz SA, Guerrero-Zotano A, Unni N, Brufsky A, Park H, Waisman J, Yang ES, Spanggaard I, Reid S, Burkard ME, Vinayak S, Prat A, Arnedos M, Bidard FC, Loi S, Crown J, Bhave M, Piha-Paul SA, Suga JM, Chia S, Saura C, Garcia-Saenz JA, Gambardella V, de Miguel MJ, Gal-Yam EN, Rapael A, Stemmer SM, Ma C, Hanker AB, Ye D, Goldman JW, Bose R, Peterson L, Bell JSK, Frazier A, DiPrimeo D, Wong A, Arteaga CL, Solit DB. Neratinib + fulvestrant + trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: outcomes and biomarker analysis from the SUMMIT trial. Ann Oncol. 2023 Oct;34(10):885-898. doi: 10.1016/j.annonc.2023.08.003. Epub 2023 Aug 18.
Harding JJ, Piha-Paul SA, Shah RH, Murphy JJ, Cleary JM, Shapiro GI, Quinn DI, Brana I, Moreno V, Borad M, Loi S, Spanggaard I, Park H, Ford JM, Arnedos M, Stemmer SM, de la Fouchardiere C, Fountzilas C, Zhang J, DiPrimeo D, Savin C, Duygu Selcuklu S, Berger MF, Eli LD, Meric-Bernstam F, Jhaveri K, Solit DB, Abou-Alfa GK. Antitumour activity of neratinib in patients with HER2-mutant advanced biliary tract cancers. Nat Commun. 2023 Feb 6;14(1):630. doi: 10.1038/s41467-023-36399-y.
Shishido SN, Masson R, Xu L, Welter L, Prabakar RK, D' Souza A, Spicer D, Kang I, Jayachandran P, Hicks J, Lu J, Kuhn P. Disease characterization in liquid biopsy from HER2-mutated, non-amplified metastatic breast cancer patients treated with neratinib. NPJ Breast Cancer. 2022 Feb 18;8(1):22. doi: 10.1038/s41523-022-00390-5.
Ulaner GA, Saura C, Piha-Paul SA, Mayer I, Quinn D, Jhaveri K, Stone B, Shahin S, Mann G, Dujka M, Bryce R, Meric-Bernstam F, Solit DB, Hyman DM. Impact of FDG PET Imaging for Expanding Patient Eligibility and Measuring Treatment Response in a Genome-Driven Basket Trial of the Pan-HER Kinase Inhibitor, Neratinib. Clin Cancer Res. 2019 Dec 15;25(24):7381-7387. doi: 10.1158/1078-0432.CCR-19-1658. Epub 2019 Sep 23.
Hanker AB, Brewer MR, Sheehan JH, Koch JP, Sliwoski GR, Nagy R, Lanman R, Berger MF, Hyman DM, Solit DB, He J, Miller V, Cutler RE Jr, Lalani AS, Cross D, Lovly CM, Meiler J, Arteaga CL. An Acquired HER2T798I Gatekeeper Mutation Induces Resistance to Neratinib in a Patient with HER2 Mutant-Driven Breast Cancer. Cancer Discov. 2017 Jun;7(6):575-585. doi: 10.1158/2159-8290.CD-16-1431. Epub 2017 Mar 8.
Efficacy and Determinants of Response to HER Kinase Inhibition in HER2 -Mutant Metastatic Breast Cancer
Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)
FG003
Neratinib + Trastuzumab
Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
FG004
Neratinib + Fulvestrant + Trastuzumab
Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
FG005
Fulvestrant
Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)
FG006
Fulvestrant + Trastuzumab
Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
FG000318 subjects
FG00145 subjects
FG00223 subjects
FG00392 subjects
FG00490 subjects
FG0057 subjects
FG0067 subjects
Treated
FG000317 subjects
FG00145 subjects
FG00222 subjects
FG00392 subjects
FG00490 subjects
FG0057 subjects
FG0067 subjects
COMPLETED
FG000231 subjects
FG00131 subjects
FG00214 subjects
FG00370 subjects
FG00432 subjects
FG0052 subjects
FG0060 subjects
NOT COMPLETED
FG00087 subjects
FG00114 subjects
FG0029 subjects
FG00322 subjects
FG00458 subjects
FG0055 subjects
FG0067 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00023 subjects
FG0013 subjects
FG0023 subjects
FG0035 subjects
FG0046 subjects
FG0050 subjects
FG0061 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG00018 subjects
FG0013 subjects
FG0020 subjects
FG0035 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other, Disease progression
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Discontinuation of study by sponsor
FG00041 subjects
FG0017 subjects
FG0025 subjects
FG00312 subjects
FG004
Not Treated
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Neratinib
Neratinib Monotherapy (Neratinib 240 mg PO daily)
BG001
Neratinib + Fulvestrant
Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)
BG002
Neratinib + Paclitaxel
Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)
BG003
Neratinib + Trastuzumab
Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
BG004
Neratinib + Fulvestrant + Trastuzumab
Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
BG005
Fulvestrant
Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)
BG006
Fulvestrant + Trastuzumab
Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000317
BG00145
BG00222
BG00392
BG00490
BG0057
BG0067
BG007580
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.4± 13.1
BG00160.6± 11.5
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000188
BG00145
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
White
BG000255
BG00138
BG002
Tumor type
Cohort by tumor type
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Breast cancer HR+ or HR-
BG00036
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Percentage of participants who are confirmed by independent central review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts).
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Cohort of cancer type and treatment
Posted
Number
percentage of participants
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
ID
Title
Description
OG000
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
OG001
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
OG002
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
Units
Counts
Participants
OG00059
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG00040.7
OG0010
OG00214.3
Primary
Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort)
Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (cervical cancer cohort).
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Cohort of cancer type and treatment
Posted
Number
percentage of participants
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
ID
Title
Description
OG000
Cervical (Neratinib)
Cervical cancer patients treated with Neratinib Monotherapy
Units
Counts
Participants
OG000
Primary
Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts)
Percentage of participants who achieve CR or PR per Response Evaluation Criteria in Sold Tumors Criteria (RECIST) v1.1, or other defined response criteria, at the first scheduled tumor assessment (all other cohorts), per RECIST (if assessed) or PERCIST.
RECISTv1.1 for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
PERCISTv1.0: Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels
Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions.
Positive Metabolic Response - Participants having either "Complete Metabolic Response" or "Part
Cohort of cancer type and treatment
Posted
Number
percentage of participant
From first treatment date to first Complete or Partial Response, whichever came earlier, assessed up to 8 or 9 weeks
ID
Title
Description
OG000
Breast Cancer (Neratinib)
Breast cancer HR+ or HR- patients treated with Neratinib Monotherapy
OG001
Breast Cancer HR+ (Neratinib + Fulvestrant)
Secondary
Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort)
Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts).
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Cohort of cancer type and treatment
Posted
Number
percentage of participants
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
ID
Title
Description
OG000
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
OG001
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
OG002
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
Secondary
Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts)
Percentage of participants who achieve CR or PR per RECIST v1.1, or metabolic complete response via PERCIST v1.0.
For RECIST, A complete or partial response that is confirmed no less than 4-weeks after the criteria for response are initially met. PERCIST criteria were used for patients without RECIST assessments.
Posted
Number
percentage of participant
From first treatment date to confirmed Complete or Partial Response, assessed up to 58 months.
ID
Title
Description
OG000
Breast Cancer (Neratinib)
Breast cancer HR+ or HR- patients treated with Neratinib Monotherapy
OG001
Breast Cancer HR+ (Neratinib + Fulvestrant)
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant)
OG002
Breast Cancer HR+ (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG003
Breast Cancer HR- (Neratinib + Trastuzumab)
Secondary
Duration of Response (DOR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
Number of confirmed responders
Posted
Median
95% Confidence Interval
month
From first response to first disease progression or death, assessed up to 58 months
ID
Title
Description
OG000
Breast Cancer HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG001
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant)
Breast cancer HR+ patients having prior CDK4/6i treated with Fulvestrant Monotherapy
OG002
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Fulvestrant + Trastuzumab)
Secondary
Duration of Response (DOR) by Investigator Review (All Cohorts)
Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
Number of confirmed responders
Posted
Median
95% Confidence Interval
month
From first response to first disease progression or death, assessed up to 58 months
ID
Title
Description
OG000
Breast Cancer HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG001
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant)
Breast cancer HR+ patients having prior CDK4/6i treated with Fulvestrant Monotherapy
OG002
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Fulvestrant + Trastuzumab)
OG003
Secondary
Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Percentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment.
Posted
Number
percentage of participant
From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months
ID
Title
Description
OG000
Breast Cancer HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG001
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant)
Breast cancer HR+ patients having prior CDK4/6i treated with Fulvestrant Monotherapy
OG002
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Fulvestrant + Trastuzumab)
Units
Counts
Secondary
Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts)
Percentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment.
Posted
Number
percentage of participant
From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months
ID
Title
Description
OG000
Breast Cancer HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG001
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant)
Breast cancer HR+ patients having prior CDK4/6i treated with Fulvestrant Monotherapy
OG002
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Fulvestrant + Trastuzumab)
OG003
Breast Cancer (Neratinib)
Breast cancer HR+ or HR- patients treated with Neratinib Monotherapy
Secondary
Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
Posted
Median
95% Confidence Interval
month
From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
ID
Title
Description
OG000
Breast Cancer HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG001
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant)
Breast cancer HR+ patients having prior CDK4/6i treated with Fulvestrant Monotherapy
OG002
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Fulvestrant + Trastuzumab)
Secondary
Progression-Free Survival (PFS) by Investigator Review (All Cohorts)
Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
Posted
Median
95% Confidence Interval
month
From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
ID
Title
Description
OG000
Breast Cancer HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG001
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant)
Breast cancer HR+ patients having prior CDK4/6i treated with Fulvestrant Monotherapy
OG002
Breast Cancer HR+ w Prior CDK4/6i (Fulvestrant + Trastuzumab)
Breast cancer HR+ patients having prior CDK4/6i treated with combination of (Fulvestrant + Trastuzumab)
Secondary
Number of Participants With Treatment-Emergent Adverse Events
The safety of neratinib in patients as measured by the incidence of treatment-emergent adverse events (TEAE), including serious adverse events (SAEs), in study participants. TEAEs are any adverse event that occurred on or after first dose of investigational product and up to 28 days after the last dose
Posted
Count of Participants
Participants
From first dose through 28 days after the last dose, assessed up to 75 months.
ID
Title
Description
OG000
Neratinib
Neratinib Monotherapy (Neratinib 240 mg PO daily)
OG001
Neratinib + Fulvestrant
Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)
OG002
Neratinib + Paclitaxel
Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)
OG003
Neratinib + Trastuzumab
Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
Time Frame
All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Neratinib
Neratinib Monotherapy (Neratinib 240 mg PO daily)
231
317
144
317
304
317
EG001
Neratinib + Fulvestrant
Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)
31
45
12
45
45
45
EG002
Neratinib + Paclitaxel
Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)
14
22
13
22
20
22
EG003
Neratinib + Trastuzumab
Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
71
92
45
92
92
92
EG004
Neratinib + Fulvestrant + Trastuzumab
Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
32
90
28
90
89
90
EG005
Fulvestrant
Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)
2
7
5
7
7
7
EG006
Fulvestrant + Trastuzumab
Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
0
7
0
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0003 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG0031 affected92 at risk
EG0040 affected90 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0003 affected317 at risk
EG0012 affected45 at risk
EG0020 affected22 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Tracheo-oesophageal fistula
Congenital, familial and genetic disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Diplopia
Eye disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG00017 affected317 at risk
EG0010 affected45 at risk
EG0023 affected22 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0004 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0004 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG00030 affected317 at risk
EG0011 affected45 at risk
EG0026 affected22 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0022 affected22 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0003 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0009 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG0004 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (25.1)
Systematic Assessment
EG00014 affected317 at risk
EG0011 affected45 at risk
EG0022 affected22 at risk
EG003
Asthenia
General disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Fatigue
General disorders
MedDRA (25.1)
Systematic Assessment
EG0003 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Gait disturbance
General disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
General physical health deterioration
General disorders
MedDRA (25.1)
Systematic Assessment
EG0003 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Oedema peripheral
General disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Pain
General disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Pyrexia
General disorders
MedDRA (25.1)
Systematic Assessment
EG0007 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Gallbladder obstruction
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Malignant biliary obstruction
Hepatobiliary disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cystitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Device related infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Influenza
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Kidney infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Liver abscess
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Lymphangitis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0003 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Sepsis
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0006 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Septic shock
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0008 affected317 at risk
EG0010 affected45 at risk
EG0022 affected22 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0012 affected45 at risk
EG0020 affected22 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Post procedural bile leak
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0004 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0004 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Troponin I increased
Investigations
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0003 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG00010 affected317 at risk
EG0010 affected45 at risk
EG0021 affected22 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0003 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0004 affected317 at risk
EG0010 affected45 at risk
EG0022 affected22 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0002 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Sacral pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0012 affected45 at risk
EG0020 affected22 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0011 affected45 at risk
EG0020 affected22 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0001 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.1)
Systematic Assessment
EG0000 affected317 at risk
EG0010 affected45 at risk
EG0020 affected22 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormones, Hormone Substitutes, and Hormone Antagonists
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0050 subjects
FG0060 subjects
3 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
46 subjects
FG0055 subjects
FG0066 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0
BG0040
BG0050
BG0060
BG0070
Between 18 and 65 years
BG000201
BG00128
BG0024
BG00357
BG00459
BG0056
BG0063
BG007358
>=65 years
BG000116
BG00117
BG00218
BG00335
BG00431
BG0051
BG0064
BG007222
69.4
± 9.4
BG00360.4± 11.1
BG00459.2± 11.6
BG00558.3± 11.2
BG00662.0± 12.4
BG00760.0± 12.4
5
BG00358
BG00489
BG0057
BG0067
BG007399
Male
BG000129
BG0010
BG00217
BG00334
BG0041
BG0050
BG0060
BG007181
21
BG00370
BG00477
BG0057
BG0065
BG007473
Asian
BG00018
BG0012
BG0020
BG0037
BG0041
BG0050
BG0060
BG00728
Black or African American
BG00016
BG0011
BG0020
BG0034
BG0044
BG0050
BG0061
BG00726
American Indian or Alaska Native
BG0002
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0073
Other
BG0006
BG0011
BG0020
BG0032
BG0040
BG0050
BG0060
BG0079
Unknown
BG0007
BG0011
BG0020
BG0034
BG0041
BG0050
BG0060
BG00713
Not Reported
BG00013
BG0012
BG0021
BG0035
BG0047
BG0050
BG0060
BG00728
0
BG0030
BG0040
BG0050
BG0060
BG00736
Breast cancer HR+
BG0000
BG00145
BG0020
BG0030
BG00431
BG0050
BG0060
BG00776
Breast cancer HR+, prior CDK46 inhibitors
BG0000
BG0010
BG0020
BG0030
BG00459
BG0057
BG0067
BG00773
Breast cancer HR-
BG0000
BG0010
BG0020
BG00321
BG0040
BG0050
BG0060
BG00721
Lung Her2 mutant cancer
BG00026
BG0010
BG0020
BG00352
BG0040
BG0050
BG0060
BG00778
Lung EGFR mutant exon 18 cancer
BG00031
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00731
Biliary tract cancer
BG00025
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00725
Cervical cancer
BG00022
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00722
Bladder/Urinary Tract cancer
BG00016
BG0010
BG00222
BG0030
BG0040
BG0050
BG0060
BG00738
Brain EGFR mutant cancer
BG00038
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00738
Colorectal cancer
BG00012
BG0010
BG0020
BG00319
BG0040
BG0050
BG0060
BG00731
Salivary gland cancer
BG00011
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00711
Endometrial cancer
BG0007
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0077
Fibrolamellar carcinoma (FLC)
BG00015
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00715
Gastroesophageal cancer
BG0007
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0077
Ovarian cancer
BG00010
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00710
HER2 NOS cancer
BG00042
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00742
HER3 NOS cancer
BG00016
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG00716
HER4 NOS cancer
BG0003
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0073
22
Title
Denominators
Categories
Title
Measurements
OG00018.2
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant)
OG002
Breast Cancer HR+ (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG003
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
OG004
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
OG005
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
OG006
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
OG007
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
OG008
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
OG009
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
OG010
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
OG011
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
OG012
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
OG013
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
OG014
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
OG015
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
OG016
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
OG017
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
OG018
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG019
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG020
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
Units
Counts
Participants
OG00036
OG00145
OG00231
OG00321
OG00426
OG00552
OG00631
OG00725
OG00816
OG00922
OG01038
OG01112
OG01219
OG0137
OG01410
OG01511
OG0167
OG01715
OG01842
OG01916
OG0203
Title
Denominators
Categories
Title
Measurements
OG00036.1
OG00142.2
OG00248.4
OG00333.3
OG0043.8
OG00515.4
OG00619.4
OG00712.0
OG0080
OG00913.6
OG0100
OG0110
OG0125.3
OG0130
OG0140
OG01536.4
OG0160
OG0170
OG0184.8
OG0190
OG0200
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
Units
Counts
Participants
OG00059
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG00030.5
OG0010
OG0020
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
OG004
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
OG005
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
OG006
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
OG007
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
OG008
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
OG009
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
OG010
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
OG011
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
OG012
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
OG013
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
OG014
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
OG015
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
OG016
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
OG017
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
OG018
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG019
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG020
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
Units
Counts
Participants
OG00036
OG00145
OG00231
OG00321
OG00426
OG00552
OG00631
OG00725
OG00816
OG00922
OG01038
OG01112
OG01219
OG0137
OG01410
OG01511
OG0167
OG01715
OG01842
OG01916
OG0203
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG00128.9
OG00235.5
OG00333.3
OG0043.8
OG0059.6
OG00632.3
OG00716.0
OG0080
OG00913.6
OG0102.6
OG0110
OG0125.3
OG0130
OG0140
OG0159.1
OG0160
OG0170
OG0182.4
OG0190
OG0200
Units
Counts
Participants
OG00024
OG0010
OG0021
Title
Denominators
Categories
Title
Measurements
OG00013.14(6.41 to NA)Upper limits of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
OG002NA(NA to NA)Median and Upper, lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
Breast Cancer (Neratinib)
Breast cancer HR+ or HR- patients treated with Neratinib Monotherapy
OG004
Breast Cancer HR+ (Neratinib + Fulvestrant)
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant)
OG005
Breast Cancer HR+ (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG006
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
OG007
Cervical Cancer (Neratinib)
Cervical cancer patients treated with Neratinib Monotherapy
OG008
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
OG009
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
OG010
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
OG011
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
OG012
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
OG013
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
OG014
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
OG015
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
OG016
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
OG017
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
OG018
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
OG019
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
OG020
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
OG021
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
OG022
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG023
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG024
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
Units
Counts
Participants
OG00023
OG0010
OG0020
OG0039
OG00413
OG00511
OG0067
OG0074
OG0081
OG0095
OG01010
OG0114
OG0120
OG0133
OG0141
OG0150
OG0161
OG0170
OG0180
OG0191
OG0200
OG0210
OG0221
OG0230
OG0240
Title
Denominators
Categories
Title
Measurements
OG00014.4(7.8 to 18.6)
OG0034.76(3.71 to 16.62)
OG0049.23(5.49 to 38.97)
OG0059.17(4.14 to NA)Upper limits of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
OG0067.28(4.17 to NA)Upper limits of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
OG0077.62(5.55 to 12.25)
OG0089.23(NA to NA)Upper and lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
OG0096.80(4.17 to NA)Upper limits of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
OG01022.24(4.01 to 30.03)
OG0113.75(2.99 to 4.67)
OG0137.20(2.76 to 7.59)
OG01419.94(NA to NA)Upper and lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
OG01612.19(NA to NA)Upper and lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
OG019NA(NA to NA)Median and Upper, lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
OG0223.71(NA to NA)Upper and lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
Participants
OG00059
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG00049.2
OG0010
OG00214.3
OG004
Breast Cancer HR+ (Neratinib + Fulvestrant)
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant)
OG005
Breast Cancer HR+ (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG006
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
OG007
Cervical Cancer (Neratinib)
Cervical cancer patients treated with Neratinib Monotherapy
OG008
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
OG009
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
OG010
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
OG011
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
OG012
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
OG013
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
OG014
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
OG015
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
OG016
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
OG017
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
OG018
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
OG019
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
OG020
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
OG021
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
OG022
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG023
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG024
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
Units
Counts
Participants
OG00059
OG0017
OG0027
OG00336
OG00445
OG00531
OG00621
OG00722
OG00826
OG00952
OG01031
OG01125
OG01216
OG01322
OG01438
OG01512
OG01619
OG0177
OG01810
OG01911
OG0207
OG02115
OG02242
OG02316
OG0243
Title
Denominators
Categories
Title
Measurements
OG00054.2
OG0010
OG0020
OG00333.3
OG00442.2
OG00554.8
OG00642.9
OG00745.5
OG00838.5
OG00930.8
OG01048.4
OG01124.0
OG01218.8
OG01331.8
OG01410.5
OG0158.3
OG01621.1
OG01714.3
OG01820.0
OG01954.5
OG0200
OG02113.3
OG02219.0
OG0236.3
OG0240
Units
Counts
Participants
OG00059
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG0008.11(6.01 to 16.39)
OG0012.27(1.61 to NA)Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
OG0024.11(1.87 to 4.11)
OG003
Breast Cancer (Neratinib)
Breast cancer HR+ or HR- patients treated with Neratinib Monotherapy
OG004
Breast Cancer HR+ (Neratinib + Fulvestrant)
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant)
OG005
Breast Cancer HR+ (Neratinib + Fulvestrant + Trastuzumab)
Breast cancer HR+ patients treated with combination of (Neratinib + Fulvestrant + Trastuzumab)
OG006
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
OG007
Cervical Cancer (Neratinib)
Cervical cancer patients treated with Neratinib Monotherapy
OG008
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
OG009
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
OG010
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
OG011
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
OG012
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
OG013
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
OG014
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
OG015
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
OG016
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
OG017
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
OG018
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
OG019
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
OG020
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
OG021
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
OG022
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG023
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
OG024
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
Units
Counts
Participants
OG00059
OG0017
OG0027
OG00336
OG00445
OG00531
OG00621
OG00722
OG00826
OG00952
OG01031
OG01125
OG01216
OG01322
OG01438
OG01512
OG01619
OG0177
OG01810
OG01911
OG0207
OG02115
OG02242
OG02316
OG0243
Title
Denominators
Categories
Title
Measurements
OG0008.3(6.0 to 12.7)
OG0014.1(1.6 to 4.1)
OG0023.9(1.9 to 4.1)
OG0033.48(1.94 to 3.88)
OG0045.36(3.71 to 9.23)
OG0058.21(4.07 to 11.01)
OG0066.24(2.10 to 10.25)
OG0075.09(1.74 to 7.23)
OG0084.17(1.87 to 8.80)
OG0094.01(2.10 to 4.57)
OG0105.75(2.27 to 9.23)
OG0112.76(1.05 to 3.75)
OG0121.77(1.68 to 3.55)
OG0133.75(1.87 to 5.62)
OG0141.81(1.02 to 2.69)
OG0151.71(1.45 to 1.87)
OG0162.04(1.81 to 3.48)
OG0171.87(1.61 to 6.87)
OG0182.37(1.48 to 7.36)
OG0195.32(1.81 to 9.26)
OG0201.74(0.82 to 2.23)
OG0213.58(1.84 to 3.71)
OG0221.84(1.74 to 2.07)
OG0231.69(1.41 to 2.04)
OG0241.71(1.12 to 1.74)
OG004
Neratinib + Fulvestrant + Trastuzumab
Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
OG005
Fulvestrant
Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)
OG006
Fulvestrant + Trastuzumab
Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)