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Antimetabolite

Neratinib + Capecitabine for Breast Cancer

Phase 2

Recruiting

Led By Ajay Dhakal

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

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

Must have

At least 18 years of age

A minimum of 28 days since the last dose of fulvestrant before registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment for patients whose tumors are HER2-negative, but show abnormal HER2 activity.

Who is the study for?

This trial is for adults with HER2-negative breast cancer that has spread to the brain, showing abnormal HER2 activity. Candidates must have measurable disease, be fit for a biopsy, and not have had certain treatments recently. They should not be pregnant or breastfeeding and must use reliable contraception.Check my eligibility

What is being tested?

The study tests the combination of Neratinib (a targeted therapy) and Capecitabine (chemotherapy) in patients whose tumors are HER2-negative but show unusual HER2 activity. It aims to assess safety and effectiveness specifically for brain metastases from breast cancer.See study design

What are the potential side effects?

Potential side effects include diarrhea, liver issues, hand-foot syndrome (redness/swelling/pain on palms/soles), nausea, vomiting, fatigue, mouth sores. Heart problems could also occur due to Neratinib.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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It has been at least 28 days since my last fulvestrant dose.

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My side effects from previous treatments have mostly gone away.

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I understand this study is experimental and I can sign the consent form.

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My breast cancer is confirmed to be HER2 negative.

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I am post-menopausal, surgically sterile, or will use birth control during and for 6 months after the study.

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My doctor thinks I might need treatment that affects my whole body now or later.

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It has been over 21 days since my last targeted cancer treatment.

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I have a tumor outside my brain that can be biopsied.

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I am able to get out of my bed or chair and move around.

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It has been over 30 days since my last experimental cancer treatment or immunotherapy.

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I am either male or female.

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My cancer has spread to my brain recently or is getting worse.

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My tumor shows abnormal HER2 activity based on the CELsignia test.

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I have triple negative breast cancer and haven't had specific cancer treatments.

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I have ER+ breast cancer and was treated with CDK4/6 inhibitors and hormone therapy for advanced disease.

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It's been over 14 days since my last chemotherapy dose, except for capecitabine.

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My blood, liver, kidneys, and clotting functions are all within normal ranges.

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I am willing to have a biopsy for research purposes.

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I have a new or growing brain tumor larger than 5 mm.

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I am healthy enough to have a biopsy.

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It's been over a week since my last hormone therapy, except for fulvestrant.

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It's been over a week since my last radiation treatment and I've recovered from any immediate side effects.

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I understand this study is experimental and I can sign the consent form.

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I have not had major surgery in the last 10 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

CNS progression free survival

overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Capecitabine and Neratinib.Experimental Treatment1 Intervention

Neratinib 240 mg PO QD Daily On-going Capecitabine 750 mg/m2 PO bid Days 1-14, 7 days off On-going

0 / 25Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

837 Previous Clinical Trials

518,095 Total Patients Enrolled

11 Trials studying Breast Cancer

1,691 Patients Enrolled for Breast Cancer

Ajay DhakalPrincipal InvestigatorUniversity of Rochester

Media Library

Capecitabine (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04965064 — Phase 2

Breast Cancer Research Study Groups: Experimental: Capecitabine and Neratinib.

Breast Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04965064 — Phase 2

Capecitabine (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04965064 — Phase 2

Frequently Asked Questions

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

What are capecitabine and neratinib most commonly used to treate?

"Cancerous growths such as malignant neoplasms, pancreatic endocrine carcinoma, and colorectal carcinoma can be managed through the administration of capecitabine and neratinib."

Answered by AI

How many people are being chosen for this clinical trial?

"The trial is currently seeking 22 participants from 1 site, as stated on clinicaltrials.gov. This information is accurate as of the trial's last update on September 23rd, 2022."

Answered by AI

Are there any risks that come with taking capecitabine and neratinib?

"While there is some data supporting the safety of the experimental combination of capecitabine and neratinib, there is currently no evidence to suggest that the drug combo is effective. Our team scores it a 2."

Answered by AI

What are the findings of other academic research projects that have included capecitabine and neratinib?

"Currently, 370 different clinical trials are investigating the combination of capecitabine and neratinib. 130 of those trials are currently in Phase 3. While most of the research is being conducted in Melbourne, Victoria, there are 13131 total locations running these studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling

Ajay Dhakal 2022. "Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965064.

All > Brain Metastases