Nerlynx

Breast Cancer

Treatment

2 FDA approvals

19 Active Studies for Nerlynx

What is Nerlynx

Neratinib

The Generic name of this drug

Treatment Summary

Neratinib is an extended adjuvant therapy used to treat Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer. It was approved by the FDA in July 2017 and is sold under the brand name Nerlynx. Research is being conducted to see if Neratinib can be used to treat other forms of cancer.

Nerlynx

is the brand name

image of different drug pills on a surface

Nerlynx Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Nerlynx

Neratinib

2017

1

Approved as Treatment by the FDA

Neratinib, also known as Nerlynx, is approved by the FDA for 2 uses like Breast Cancer and Breast Cancer .

Breast Cancer

Breast Cancer

Effectiveness

How Nerlynx Affects Patients

Neratinib is a medicine that acts against certain types of cancer caused by EGFR, HER2, and HER4. It works by blocking certain proteins in the body that can lead to cancer growth.

How Nerlynx works in the body

Neratinib blocks cancer cells from sending signals to each other. It does this by stopping certain proteins from attaching to receptors on the cancer cells, which prevents those cells from receiving messages. This limits the cancer cells' ability to grow and spread.

When to interrupt dosage

The proposed measure of Nerlynx is contingent upon the manifested condition. The dose also changes as per the mode of delivery enumerated in the table beneath.

Condition

Dosage

Administration

Breast Cancer

, 40.0 mg

, Oral, Tablet - Oral, Tablet, Tablet, film coated - Oral, Tablet, film coated

Warnings

There are 20 known major drug interactions with Nerlynx.

Common Nerlynx Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The serum concentration of Abemaciclib can be increased when it is combined with Neratinib.

Axitinib

Major

The serum concentration of Axitinib can be increased when it is combined with Neratinib.

Bendamustine

Major

The serum concentration of Bendamustine can be increased when it is combined with Neratinib.

Binimetinib

Major

The serum concentration of Binimetinib can be increased when it is combined with Neratinib.

Bortezomib

Major

The serum concentration of Bortezomib can be increased when it is combined with Neratinib.

Nerlynx Toxicity & Overdose Risk

Taking neratinib may cause diarrhea, liver damage, vomiting, dehydration, skin infection, kidney failure, nausea, tiredness, and abdominal pain. These side effects have been reported in clinical trials in patients taking neratinib.

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Nerlynx Novel Uses: Which Conditions Have a Clinical Trial Featuring Nerlynx?

Presently, 677 active clinical trials are investigating the potential of Nerlynx to treat Breast Cancer.

Condition

Clinical Trials

Trial Phases

Breast Cancer

21 Actively Recruiting

Phase 2, Phase 1, Not Applicable

Nerlynx Reviews: What are patients saying about Nerlynx?

2.7

Patient Review

6/2/2019

Nerlynx for HER2 Positive Breast Cancer

I had to limit my intake to four a day because it was really tough on my stomach. I don't have a gallbladder, and I suffer from bad acid reflux, so this drug was harder on me than my big chemo treatments. I took it for 10 months, but kept getting worse instead of better, with diarrhea. I've been off of it since May 1st of this year, and hopefully I'll start feeling better soon.
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Patient Q&A Section about nerlynx

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

What is Nerlynx used for?

"NERYLNX is a prescription drug used to treat early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who have previously been treated with a drug called trastuzumab."

Answered by AI

Is Nerlynx a chemo drug?

"Neratinib is a targeted therapy drug that is used to cancer cells. It attacks cancer cells by interfering with their ability to grow and divide."

Answered by AI

Is Nerlynx the same as Herceptin?

"Nerlynx is a drug that is approved by the FDA to treat early stage HER2-positive breast cancer. Nerlynx helps to prevent the cancer from returning in patients who have previously taken the drug trastuzumab. Nerlynx is used as an adjuvant therapy, which is a treatment that is used to prevent cancer from returning."

Answered by AI

How long do you take Nerlynx?

"If you're taking an acid reducer, you should take NERLYNX at least 2 hours before or 10 hours after. NERLYNX is usually taken for an entire year. If you miss a dose, just skip it and continue with your regular schedule."

Answered by AI

Clinical Trials for Nerlynx

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Supplemental Imaging for Breast Cancer

25 - 55
Female
St Louis, MO

Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers). The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.

Waitlist Available
Has No Placebo

Washington University School of Medicine

Tabassum Ahmad, M.D.

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Algorithm-Based Treatment Options for Advanced Breast Cancer

18 - 120
All Sexes
Bethesda, MD

Background: Breast cancer is the most common cancer in US women. There are different types of breast cancers; some are aggressive and difficult to treat. Researchers want to know if an algorithm (ENLIGHT) can help choose approved drugs that will treat these cancers more effectively. Objective: To test whether ENLIGHT can find better treatments for aggressive breast cancers. Eligibility: People aged 18 years and older with triple-negative or endocrine therapy resistant breast cancer; the cancer must have either failed to respond to treatment or come back after treatment. Design: Participants will be screened. A sample of tissue taken from the tumor will be tested using ENLIGHT as well as another method (TruSight Oncology 500). Participants will be assigned to 1 of 3 groups based on the algorithm search results: Group 1: No drug option was recommended. Participants will continue with their standard treatment with their local doctors. Group 2: A drug already approved for the participant's disease was recommended, but the participant has not yet received it. These results will be sent to the participant's local doctors. Participants may return to the NIH if their disease gets worse after using the suggested drugs. Group 3: A drug approved for other uses was recommended. Participants will be treated with the recommended drugs at the NIH; their care will be managed by an NIH doctor. They will continue to receive treatment as long as the drugs are helping them. They will have follow-up visits for 2 years after treatment ends. Participants who are not treated at the NIH will be contacted for a check on their health every 3 months for 2 years.

Recruiting
Has No Placebo

National Institutes of Health Clinical Center

Padma S Rajagopal, M.D.

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ChatGPT Education for Breast Reconstruction in Breast Cancer

18+
All Sexes
Saint Louis, MO

In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT-generated patient education regarding possible reconstruction options) or the control group (usual patient education). All patients will complete a survey following their in-person consultation to assess their experience and overall satisfaction with the consultation process. Additionally, participating surgeons will complete a separate survey to evaluate their consultation experience, satisfaction, and to assess the accuracy and clinical utility of the ChatGPT-generated patient education materials. The surveys are designed to gather information on patient characteristics, organizational health literacy according to Brega et al. Other survey questions have been designed to meet the outcomes of this study and have not been based on previously published surveys.

Recruiting
Has No Placebo

Washington University School of Medicine (+1 Sites)

Saif M Badran, M.D., Ph.D., FRCS

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Exercise Programs for Cancer

18+
All Sexes
Calgary, Canada

EXCEL will provide online and, where feasible, in-person exercise programs to individuals living with and beyond cancer (ILWBC). Research has shown that targeted programs that include tailored exercise prescriptions are more successful in helping individuals with chronic disease to incorporate physical activity and exercise into their daily routines. While ILWBC are advised by healthcare professionals (HCPs) to engage in exercise, there is a lack of cancer-specific exercise programs and cancer-trained exercise specialists in Canada, outside of the research setting. Considering the negative impact cancer and its treatments have on fitness and physical activity levels, community-based efforts towards improving access, uptake and maintenance of exercise programming are needed. This study will evaluate the benefits of a community-based or online EXCEL exercise program for people living with and beyond cancer across Canada, using a streamlined intake process compared to the original EXCEL Study (HREBA.CC-20-0098, NCT04478851). This 8 to 12-week program (intervention) will be delivered in-person or over virtual platform. It includes twice weekly supervised exercise classes.

Recruiting
Has No Placebo

University of Calgary (+4 Sites)

Nicole Culos-Reed, PhD

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Web-Based Intervention for Cancer Pain in Breast Cancer Survivors

18+
Female
Austin, TX

This study is funded by the HEAL Initiative (https://heal.nih.gov/). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching/support program for cancer pain management (CAPA) that was culturally tailored to Asian American breast cancer survivors using multiple unique features. However, CAPA rarely considered depressive symptoms accompanying pain in its design or components, and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD. The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality (CAI) and to test the efficacy of CAI in improving cancer pain experience of ABD. The specific aims are to: a) develop and evaluate CAI through an expert review and a usability test (R61 phase); b) determine whether the intervention group (that uses CAI and usual care) will show significantly greater improvements than the active control group (that uses CAPA and usual care) in primary outcomes (cancer pain management and cancer pain experience including depressive symptoms) from baseline to post 1-month and post 3-months; c) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences) that mediate the intervention effects of CAI on the primary outcomes; and d) determine whether the effects of CAI on the primary outcomes are moderated by selected background, disease, genetic, and situational factors. This study is guided by the Bandura's Theory and the stress and coping framework by Lazarus and Folkman. The R61 phase includes: (a) the intervention development process, (b) a usability test among 15 ABD, 15 family members, and 15 community gatekeepers; and (c) an expert review among 10 experts in oncology. The R33 phase adopts a randomized repeated measures control group design among 300 ABD. Long-term goals are: (a) to extend and test CAI in various healthcare settings with diverse subgroups of ABD, (b) examine the costeffectiveness, sustainability, and scalability of CAI in the settings, and (c) translate CAI into health care for ABD.

Recruiting
Has No Placebo

The University of Texas at Austin

Eun Ok Im

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TEAM-based Care for Cancer

18 - 79
All Sexes
Durham, NC

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with \>1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be \~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

Waitlist Available
Has No Placebo

Duke University Medical Center

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