Your session is about to expire
← Back to Search
Aromatase Inhibitor
Neratinib + Endocrine Therapy + Trastuzumab for Breast Cancer
Phase 2
Recruiting
Led By Ruth O'Regan, MD
Research Sponsored by Ruth O'Regan
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 24 weeks
Awards & highlights
Study Summary
This trial is testing neratinib, an aromatase inhibitor, and trastuzumab as a treatment for breast cancer.
Who is the study for?
This trial is for postmenopausal women over 18 with stage I-III invasive breast cancer that's larger than 10mm, HER2-positive, and ER-positive. Candidates must have a good performance status, resectable cancer suitable for pre-op therapy, agree to biopsies, and have proper heart function. Excluded are those needing strong CYP3A4 inhibitors/inducers or with active infections, recent major surgery side effects, GI issues affecting drug absorption, metastatic disease or certain cardiovascular conditions.Check my eligibility
What is being tested?
The study tests the combination of Neratinib (a targeted therapy), an aromatase inhibitor (Letrozole or Anastrozole), and Trastuzumab (an immune therapy) given for 24 weeks before surgery in treating HER2-positive breast cancer. The initial three weeks involve varying combinations of these drugs followed by standard care after surgery.See study design
What are the potential side effects?
Potential side effects include diarrhea from Neratinib; Letrozole or Anastrozole may cause hot flashes and joint pain; Trastuzumab can lead to heart problems and infusion reactions. Side effects vary among individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic Complete Response (pCR)
Secondary outcome measures
Assess Adverse Events
Measure Residual Disease
Pathological Complete Response (pCR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: AExperimental Treatment3 Interventions
Weeks 1-3* patients receive either (a) Neratinib, (b) Letrozole or Anastrozole or (c) Neratinib + Letrozole or Anastrozole
Weeks 4-24 patients receive Neratinib + Letrozole or Anastrozole and Trastuzumab
*Starting drug intervention varies for the first 3 weeks depending on arms: a, b, and c by randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
2014
Completed Phase 2
~1970
Trastuzumab
2014
Completed Phase 4
~5190
Find a Location
Who is running the clinical trial?
Ruth O'ReganLead Sponsor
Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
9,894 Total Patients Enrolled
13 Trials studying Breast Cancer
4,349 Patients Enrolled for Breast Cancer
University of RochesterOTHER
838 Previous Clinical Trials
518,519 Total Patients Enrolled
11 Trials studying Breast Cancer
1,665 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot take certain medications that affect the way your body processes other drugs during the study.You have invasive breast cancer that is stage I, II, or III and is larger than 10 millimeters.You have been tested positive for HER2 according to the latest ASCO-CAP criteria.You have a high level of estrogen receptor (ER) in your body.You have breast cancer that can be removed with surgery, and your doctor thinks it's best to have treatment before the operation.You have a serious infection that needs treatment throughout your body.Your doctor thinks you should take either letrozole or anastrozole.If you have chronic hepatitis B, your viral load must be undetectable with treatment. If you have had hepatitis C, you must have been treated and cured.You have breast cancer that has spread extensively in the breast or is causing inflammation.There is evidence that the cancer has spread to other parts of the body. You don't need a special scan to check for this.You have had or currently have another type of cancer that could affect the safety or effectiveness of the treatment being studied.You had a stroke or mini-stroke in the past year.You had a serious heart condition or chest pain within the past 6 months.You have severe heart problems that are causing symptoms, or your heart's pumping function is below a certain level.You have a serious heart rhythm problem, unless you have a pacemaker.You or someone in your family has a heart condition that can cause sudden, dangerous heartbeats.You have had a type of blood disorder called myelodysplastic syndrome or acute myeloid leukemia in the past.You need to provide a sample of tissue from the initial biopsy before starting treatment.Your heart's pumping ability is normal, as shown by a recent heart scan.Show that your blood, kidneys, and liver are working well.People with HIV who are effectively managing their condition with medication and have had undetectable levels of the virus for at least 6 months can participate in this trial.
Research Study Groups:
This trial has the following groups:- Group 1: A
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.
For what purpose is A commonly prescribed?
"A is a viable option for managing brca1 gene-related issues, including breast cancer and inflammatory breast cancer (IBC). Additionally, 2 to 3 years of tamoxifen therapy can be utilized in tandem with A."
Answered by AI
Could you provide an account of other experiments conducted with A?
"Presently, there are 362 active clinical trials researching A with 91 of those studies being in Phase 3. These investigations are primarily taking place in Seattle, Washington; however, there is a total of 26633 sites conducting research related to this topic."
Answered by AI
Does this research endeavor still accept participants?
"According to clinicaltrials.gov, recruitment for this medical trial is still ongoing. The research project was first uploaded on the 21st of July 2022 and underwent its last modification on the 10th of October 2022."
Answered by AI
Are there any known dangers associated with utilizing A?
"This Phase 2 trial has not yet yielded efficacy data, thus our team at Power gave a safety rating of 2 for medication A."
Answered by AI
How many participants are currently undergoing treatment in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research is still in the process of recruiting participants for its trials which first began on July 21st 2022 and was most recently revised on October 10th 2022. 48 patients are needed from 1 single medical site."
Answered by AI
Who else is applying?
What site did they apply to?
Penn State Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger