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Anti-metabolites
Capecitabine + Neratinib for Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Chau Dang, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
Histologically confirmed MBC, current stage IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat HER2 positive breast cancer. The drugs are neratinib and capecitabine. The researchers want to see if this new combination is safe and if it has any effect on people with this type of cancer.
Who is the study for?
This trial is for adults with stage IV HER2-positive metastatic breast cancer who've had trastuzumab-based therapy. They can have up to four prior chemo treatments in the metastatic setting but not neratinib with capecitabine. Stable brain lesions are okay, and they must have a good heart function (LVEF ≥50%) and be able to perform daily activities (ECOG 0-1). Women must use effective contraception.Check my eligibility
What is being tested?
The study tests the safety of neratinib combined with capecitabine at different doses in patients with advanced breast cancer. Capecitabine is FDA-approved; neratinib isn't yet approved for this use. The focus is on whether changing the dosing schedule can improve safety compared to standard schedules.See study design
What are the potential side effects?
Potential side effects include diarrhea, liver issues, blood cell count changes, fatigue, nausea, hand-foot syndrome from capecitabine, and possible heart problems or severe allergic reactions due to neratinib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my daily activities without help.
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My breast cancer is confirmed to be at stage IV.
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My cancer shows high levels of HER2.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 (MTD)
Trial Design
1Treatment groups
Experimental Treatment
Group I: capecitabine 7/7 with neratinibExperimental Treatment3 Interventions
In the phase I portion of the study, a 3+3 design will be used. Once the MTD is reached, the phase II portion will enroll up to 24 patients. Capecitabine will be taken orally in AM and PM (at the assigned dose per cohort) 7 days on and 7 days off. Neratinib is given as 240 mg daily continuously without stopping. A cycle is 28 days. Patients will be seen on Day 1 of each cycle (+/- 3 days).
The MD has been determined as 240mg of neratinib and 1000mg BID of capecitabine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Neratinib
2014
Completed Phase 2
~1970
Find a Location
Who is running the clinical trial?
Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
9,908 Total Patients Enrolled
13 Trials studying Breast Cancer
4,363 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,776 Total Patients Enrolled
202 Trials studying Breast Cancer
81,103 Patients Enrolled for Breast Cancer
Chau Dang, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
243 Total Patients Enrolled
3 Trials studying Breast Cancer
178 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had previous cancer treatments, including neratinib and capecitabine.My heart's electrical cycle is longer than normal or I've had specific heart rhythm issues.My cancer can be measured or not, according to RECIST v1.1 standards.I've had up to 4 chemotherapy treatments and trastuzumab but not neratinib for my metastatic cancer.I can carry out all my daily activities without help.Women who can have babies need to have a negative pregnancy test.I have not had a fever over 101.3°F or any unexplained infection in the last 2 weeks.I have a long-term stomach or bowel problem that causes serious diarrhea.Your bilirubin, AST, and ALT levels must be within a certain range, and your creatinine levels must also be within a certain range.I had radiation therapy less than 14 days before starting the trial treatment.I do not have any severe heart conditions or recent heart attacks.I haven't had major surgery or cancer treatment in the last 4 weeks.I've had high doses of specific chemotherapy drugs.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.My cancer shows high levels of HER2.My breast cancer is confirmed to be at stage IV.Your heart's pumping function is normal, as measured by a MUGA or ECHO test, with a left ventricular ejection fraction (LVEF) of 50% or higher.I am 18 years old or older.Your blood counts need to be within a certain range:
- White blood cells above 3000
- Neutrophils above 1000
- Platelets above 50,000
- Hemoglobin above 8.0I am allergic to 5-fluorouracil or similar drugs.My brain lesions have been stable for 2 months or more after treatment.You have active hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: capecitabine 7/7 with neratinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other examples of research done on Capecitabine?
"Withington Hospital first studied capecitabine in 2005 and, to date, there have been a total of 580 completed studies. Currently, 370 clinical trials are still ongoing; many of these out of Commack, Connecticut."
Answered by AI
How many test subjects are taking part in this experiment?
"No, this particular study has already completed recruitment. Although, if you're looking for other studies, there are 2698 trials concerning breast cancer and 370 involving Capecitabine that are still enrolling patients."
Answered by AI
Are people with the required qualifications able to enroll in this experiment at this time?
"This particular trial is not looking for candidates at the moment. However, it was last updated on April 15th, 2022. There are 2698 clinical trials related to breast cancer and 370 trials concerning Capecitabine that are actively enrolling participants if you're interested in other studies."
Answered by AI
At how many different sites is this clinical trial being conducted?
"There are 10 study centres currently enrolling patients, these include Memorial Sloan Kettering Commack in Commack, Connecticut, and Hartford Healthcare Cancer Institute @ Hartford Hospital in Hartford, Pennsylvania."
Answered by AI
What are the indications for Capecitabine?
"Cancerous tumours such as malignant neoplasms, pancreatic endocrine carcinoma, and colorectal carcinoma can be treated using Capecitabine."
Answered by AI
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