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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
No Placebo-Only Group
Summary
This trial involves treating breast cancer patients with three drugs: neratinib, an aromatase inhibitor, and trastuzumab. These drugs work together to block cancer growth signals, lower estrogen levels, and help the immune system attack cancer cells. The treatment is aimed at patients with HER2-positive breast cancer who may not respond well to standard treatments. Trastuzumab is a well-established treatment for HER2-positive breast cancer, often used in combination with other therapies.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathologic Complete Response (pCR)
Secondary study objectives
Assess Adverse Events
Measure Residual Disease
Pathological Complete Response (pCR)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer, particularly those targeting HER2 and EGFR, include Tyrosine Kinase Inhibitors (TKIs) like Neratinib and monoclonal antibodies like Trastuzumab. TKIs work by blocking the enzymatic activity of tyrosine kinases, which are involved in the signaling pathways that promote cancer cell growth and survival.
Monoclonal antibodies, on the other hand, bind to specific proteins on the surface of cancer cells, marking them for destruction by the immune system or blocking the signals that stimulate their growth. These targeted therapies are important for breast cancer patients as they offer a more personalized treatment approach, potentially leading to better outcomes and fewer side effects compared to conventional chemotherapy.
Resistance mechanisms of epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients: A meta-analysis.Targeted Approaches Applied to Uncommon Diseases: A Case of Salivary Duct Carcinoma Metastatic to the Brain Treated with the Multikinase Inhibitor Neratinib.
Resistance mechanisms of epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients: A meta-analysis.Targeted Approaches Applied to Uncommon Diseases: A Case of Salivary Duct Carcinoma Metastatic to the Brain Treated with the Multikinase Inhibitor Neratinib.
Find a Location
Who is running the clinical trial?
Ruth O'ReganLead Sponsor
Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
10,111 Total Patients Enrolled
13 Trials studying Breast Cancer
4,340 Patients Enrolled for Breast Cancer
University of RochesterOTHER
863 Previous Clinical Trials
544,011 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.
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