Tyrosine Kinase Inhibitor
Neratinib for Breast Cancer
M D Anderson Cancer Center, Houston, TX
Targeting 8 different conditionsNeratinib +6 morePhase 1 & 2Waitlist AvailableLed by Rachel LaymanResearch Sponsored by M.D. Anderson Cancer CenterEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow upsup to 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group
Study Summary
This trial is testing neratinib, pertuzumab, trastuzumab, and paclitaxel as possible treatments for metastatic breast cancer.
Eligible Conditions
- Stage III Breast Cancer
- Stage IV Breast Cancer
- Inflammatory Breast Cancer
- Breast Cancer
- Metastatic Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow ups ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of neratinib, pertuzumab, trastuzumab and paclitaxel treatment defined as dose limiting toxicities of grade 3 or higher
Pathologic complete response (pCR) rate determined by pCR in breast and axillary lymph nodes (pCR breast & nodes) in HER2+ and HER2-/hormone receptor (HR)+ inflammatory breast cancer treated with neratinib-based treatment
Secondary outcome measures
Incidence of adverse events of combination therapy
Progression-free survival rate of HER2+, and HER2-/HR+ inflammatory breast cancer subgroups
Side effects data
From 2021 Phase 1 & 2 trial • 49 Patients • NCT02236000100%
Nausea
100%
Aspartate aminotransferase increased
100%
Diarrhoea
83%
Platelet count decreased
67%
Constipation
67%
Alanine aminotransferase increased
67%
Fatigue
67%
Lymphocyte count decreased
50%
Hypokalaemia
50%
Hypertension
50%
Weight decreased
50%
Vomiting
33%
Nasal congestion
33%
Oropharyngeal pain
33%
Gastroesophageal reflux disease
33%
Headache
33%
Upper respiratory tract infection
33%
Hypocalcaemia
33%
Hypernatraemia
33%
Hyponatraemia
33%
Epitaxis
33%
Anaemia
33%
Blood alkaline phosphatase increased
33%
Neutrophil count decreased
33%
White blood cell count decreased
17%
Dry mouth
17%
Abdominal distension
17%
Pain
17%
Dysgeusia
17%
Rash maculo-papular
17%
Urinary tract infection
17%
Abdominal pain upper
17%
Rhinitis allergic
17%
Depression
17%
Dermatitis acneiform
17%
Influenza like illness
17%
Leukopenia
17%
Lip infection
17%
Abdominal pain
17%
Hypotension
17%
Confusional state
17%
Hypoalbuminaemia
17%
Dehydration
17%
Peripheral sensory neuropathy
17%
Back pain
17%
Myalgia
17%
Sinus tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 Neratinib 120mg; T-DM1 3.6mg/kg
Phase 1 Neratinib 160mg; T-DM1 3.6mg/kg
Phase 1 Neratinib 200mg; T-DM1 3.6mg/kg
Phase 1 Neratinib 240mg; T-DM1 3.6mg/kg
Neratinib and T-DM1 Part 1 (Phase 1)
Neratinib and T-DM1Part 1 (Phase 2)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group C (Cohort 2)Experimental Treatment5 Interventions
Patients receive neratinib PO QD on days 1-21, paclitaxel IV over 1-3 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery/ Patients then receive doxorubicin and cyclophosphamide as in Group B. Patients then undergo standard of care surgery.
Group II: Group B (Cohort 1 Phase II)Experimental Treatment7 Interventions
Patients receive neratinib, paclitaxel, pertuzumab, and trastuzumab as in Group A. Patients then receive doxorubicin IV and cyclophosphamide IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery.
Group III: Group A (Cohort 1 Phase Ib)Experimental Treatment5 Interventions
Patients receive neratinib PO QD on days 1-21, paclitaxel IV over 1-3 hours on days 1, 8, and 15, pertuzumab IV over 1 hour on day 1, and trastuzumab IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without progression or excessive toxicity with metastatic disease may receive up to 4 additional courses and with locally advanced disease may receive up to 2 additional courses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Pertuzumab
FDA approved
Neratinib
FDA approved
Trastuzumab
FDA approved
Cyclophosphamide
FDA approved
Daunorubicin
FDA approved
Find a site
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,872 Previous Clinical Trials
1,781,003 Total Patients Enrolled
145 Trials studying Breast Cancer
31,706 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,368 Previous Clinical Trials
41,216,024 Total Patients Enrolled
930 Trials studying Breast Cancer
1,540,025 Patients Enrolled for Breast Cancer
Rachel LaymanPrincipal Investigator
M.D. Anderson Cancer Center2 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Breast Cancer
56 Patients Enrolled for Breast Cancer
Rachel Layman, MDPrincipal Investigator
M.D. Anderson Cancer Center1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Breast Cancer
11 Patients Enrolled for Breast Cancer
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has any other research been conducted on Neratinib?
"Currently, there are 1893 independent investigations into Neratinib with 423 of them in their terminal phase. Most of the trials take place in Seattle, Washington but they span 79307 different sites across the globe."
Answered by AI
To what maladies is Neratinib typically administered?
"Neratinib is often prescribed for the management of cyclophosphamide and can be effective in treating a variety of conditions, including Kaposi's Sarcoma AIDS related, leukemia, and locally advanced non-small cell lung cancer."
Answered by AI
Is the enrollment process for this experiment still open?
"Currently, this study is no longer accepting participants. This investigation was initially posted on January 29th 2018 and had its latest update on July 13th 2022. If you are searching for alternate trials, 4568 studies related to inflammatory breast neoplasms and 1893 clinical investigations concerning Neratinib are currently recruiting patients."
Answered by AI
Is this investigation a pioneering endeavor?
"As of today, there are 1,893 live trials involving Neratinib spanning 86 countries and 3723 cities. The inaugural trial for this drug was sponsored by Alfacell in 1997; it included 300 participants and progressed up to its Phase 3 approval stage. Since then, an additional 3233 studies have been conducted on the medication."
Answered by AI
How many volunteers are taking part in this medical experiment?
"At this time, participants are not being accepted into the clinical trial that was first launched in January of 2018 and last updated on July 13th 2022. If one wishes to explore other medical studies, there are currently 4568 trials actively recruiting patients with inflammatory breast neoplasms and 1893 for Neratinib-related treatments which require enrolment."
Answered by AI