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Estrogen Receptor Antagonist

Neratinib for Breast Cancer

Phase 2
Waitlist Available
Led By Ian Krop, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is studying how well Neratinib works with or without Fulvestrant in treating patients with HER2-positive breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Duration Of Responses
Overall Response Rate
Overall Survival

Side effects data

From 2022 Phase 2 trial • 11 Patients • NCT03094052
100%
Diarrhea
100%
Constipation
82%
Nausea
45%
Fatigue
45%
Abdominal distension
36%
Headache
36%
Dizziness
27%
Hot flashes
27%
Pruritus
27%
Dyspnea
27%
Weight loss
27%
Vomiting
27%
Anorexia
18%
Dysgeusia
18%
Alanine aminotransferase increased
18%
Aspartate aminotransferase increased
18%
Fever
18%
Gastrointestinal disorders - Other, specify
18%
Abdominal pain
18%
Bloating
18%
Sinus bradycardia
18%
Skin and subcutaneous tissue disorders - Other, specify
9%
Anxiety
9%
Cholecystitis
9%
Mucositis oral
9%
Paresthesia
9%
Rash maculo-papular
9%
Upper respiratory infection
9%
Fracture
9%
Back pain
9%
Joint range of motion decreased
9%
Vaginal dryness
9%
Lymphedema
9%
Anal hemorrhage
9%
Muscle weakness upper limb
9%
Musculoskeletal and connective tissue disorder - Other, specify
9%
Vaginal hemorrhage
9%
Chills
9%
Vaginal discharge
9%
Gastroesophageal reflux disease
9%
Creatinine increased
9%
Bruising
9%
Vaginal infection
9%
Arthralgia
9%
Pain
9%
Urinary tract pain
9%
Wheezing
9%
Ejection fraction decreased
9%
Peripheral sensory neuropathy
9%
Insomnia
9%
Flatulence
9%
Flu like symptoms
9%
Rash acneiform
9%
Oral dysesthesia
9%
Stomach pain
9%
General disorders and administration site conditions - Other, specify
9%
Infections and infestations - Other, specify
9%
Fall
9%
Neck pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Neratinib)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Neratinib + FulvestrantExperimental Treatment2 Interventions
Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets) Fulvestrant will be administered intramuscular as an injection (shot) on day 1 and 15 of cycle 1, day 1 of cycle 2, and then on day 1 of each subsequent cycle. Fulvestrant is dosed as 250 mg/5mL (x2) for a total of 500 mg via intramuscular injection (two injections).
Group II: NeratinibExperimental Treatment1 Intervention
Neratinib will be administered orally once daily Neratinib is dosed at 240mg (six 40mg tablets)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Neratinib
2014
Completed Phase 2
~1970

Find a Location

Who is running the clinical trial?

Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
9,921 Total Patients Enrolled
13 Trials studying Breast Cancer
4,376 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,965 Total Patients Enrolled
141 Trials studying Breast Cancer
22,596 Patients Enrolled for Breast Cancer
Ian Krop, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
479 Total Patients Enrolled
4 Trials studying Breast Cancer
399 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Has Neratinib been given the okay by the FDA?

"Neratinib is still being studied in Phase 2 trials, so there is not a lot of evidence surrounding its efficacy. However, it did receive a safety score of 2."

Answered by AI

How many people are allowed to be a part of this research project?

"No, this trial is no longer recruiting individuals. The date when the study was first posted was October 25th, 2017 and the most recent edit happened on March 2nd, 2022. For patients looking for active trials, there are 2698 breast cancer studies and 157 Neratinib clinical trials that are still open to participants."

Answered by AI

To what purpose is Neratinib most often put?

"The pik3ca gene mutation, which is often associated with malignant neoplasms and disease progression, can be managed through Neratinib treatment."

Answered by AI

How does Neratinib's safety profile compare to similar drugs?

"Neratinib was first trialled in 2004 at Lowell General Hospital. Since then, there have been a total of 120 completed studies with 157 more currently underway. A high concentration of these active clinical trials are based out of Boston in Massachusetts."

Answered by AI

Are there any other facilities in North America conducting this research?

"So far, this study has been conducted out of the Dana Farber Cancer Institute in Boston, Massachusetts, Dana-Farber/New hampshire Oncology-Hematology in Londonderry, New Hampshire, and The Ohio State University in Columbus, Ohio with 6 other locations."

Answered by AI

Are new participants still being accepted for this experiment?

"This study is no longer enrolling patients. The original posting was on October 25th, 2017 and the last update was March 2nd, 2022. However, there are 2698 other trials involving breast cancer that are still recruiting participants and 157 clinical studies exploring Neratinib's efficacy with actively seeking enrolled subjects."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer
Jose Pablo Leone 2017. "Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03289039.
~3 spots leftby Apr 2025
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