Tyrosine Kinase Inhibitor

Neratinib for Breast Cancer

West Cancer Center, Germantown, TN

Targeting 3 different conditionsNeratinibPhase 2Waitlist AvailableLed by Gregory A Vidal, MD.,PhDResearch Sponsored by West Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patient

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up15 weeks

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Study Summary

This trial is testing a new combination drug treatment for early stage triple-negative breast cancer patients who show enhanced HER2 signaling.

Eligible Conditions

Breast Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You are a woman.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The percentage of patients experiencing ≥ 20% response to neratinib only therapy

rate of pathologic complete response (pCR)

Secondary outcome measures

Clinical complete response (cCR)

Increase in the number of patients completing neratinib prescription with the use of web based symptom monitoring

Residual cancer burden (RCB) 0-1

+2 more

Side effects data

From 2021 Phase 1 & 2 trial • 49 Patients • NCT02236000

100%

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%

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

TNBC patients with HER2 signal positive are treated with neratinib for 3 weeks followed by 12 weeks of neratinib in combination with weekly paclitaxel and carboplatin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neratinib

FDA approved

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Puma Biotechnology, Inc.Industry Sponsor

54 Previous Clinical Trials

9,669 Total Patients Enrolled

14 Trials studying Breast Cancer

4,397 Patients Enrolled for Breast Cancer

West Cancer CenterLead Sponsor

4 Previous Clinical Trials

798 Total Patients Enrolled

Celcuity, Inc.Industry Sponsor

6 Previous Clinical Trials

935 Total Patients Enrolled

3 Trials studying Breast Cancer

898 Patients Enrolled for Breast Cancer

Gregory A Vidal, MD.,PhDPrincipal Investigator

West Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people total can join this clinical trial?

"That is correct, the online clinicaltrial.gov registry confirms that this study is currently recruiting participants. The trial was first posted on 6/21/2019 and updated as recently as 10/9/2020. Currently, 27 more patients are needed at a single location."

Answered by AI

Are researchers looking for more participants in this clinical trial?

"Yes, this clinical trial is recruiting participants. The latest update on the study was on October 9th, 2020 and it was first posted June 21st, 2019 according to the information available on clinicaltrials.gov"

Answered by AI

Is there a high margin of error for Neratinib?

"There is some data supporting Neratinib's safety, but since this is a Phase 2 trial and there is no efficacy data yet, it received a score of 2."

Answered by AI

Does previous research support the use of Neratinib in this case?

"At this time, there are a total of 20 different clinical trials underway that are focusing on Neratinib. Of these active studies, 0 are in Phase 3. Out of the 130 locations running these trials, most are situated in Richmond, Virginia."

Answered by AI

What are the therapeutic goals of this scientific investigation?

"The primary objective of the study, which will be measured over a period of 15 weeks, is to determine the percentage of patients who respond to neratinib therapy. Additionally, the study will evaluate secondary outcomes including patient completion rates and residual cancer burden."

Answered by AI

Recent research and studies

BMC CancerJournal

Development of a Test That Measures Real-time HER2 Signaling Function in Live Breast Cancer Cell Lines and Primary Cells

Huang, Yao, David J. Burns, Benjamin E. Rich, Ian A. MacNeil, Abhijit Dandapat, Sajjad M. Soltani, Samantha Myhre, et al.. 2017. “Development of a Test That Measures Real-time HER2 Signaling Function in Live Breast Cancer Cell Lines and Primary Cells”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-017-3181-0.

OncotargetJournal

A Functional Signal Profiling Test for Identifying a Subset of Her2-negative Breast Cancers with Abnormally Amplified HER2 Signaling Activity

Huang, Yao, David J Burns, Benjamin E Rich, Ian A MacNeil, Abhijit Dandapat, Sajjad M. Soltani, Samantha Myhre, et al.. 2016. “A Functional Signal Profiling Test for Identifying a Subset of Her2-negative Breast Cancers with Abnormally Amplified HER2 Signaling Activity”. Oncotarget. Impact Journals, LLC. doi:10.18632/oncotarget.12480.

clinicaltrials.govStudy

Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast

2019. "Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03812393.