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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 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

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.

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

Anastrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04886531 — Phase 2
Breast Cancer Research Study Groups: A
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT04886531 — Phase 2
Anastrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04886531 — Phase 2
~15 spots leftby Oct 2025