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Aromatase Inhibitor

Combination Therapy for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Amy Tiersten, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of HER2 positive metastatic breast cancer in either a primary or metastatic site, if 3+ by an IHC method defined as uniform membrane staining for HER2 in 10% or more of tumor cells or demonstrate HER2 gene amplification by an ISH method (single probe, average HER2 copy number ≥6.0 signals/cell; dual probe HER2/CEP17 ratio ≥2.0 with an average HER2 copy number ≥4.0 signals/cell; dual probe HER2/chromosome enumeration probe (CEP) 17 ratio ≥2.0 with an average HER2 cop number <4.0 signals/cell; and HER2/CEP17 ratio <2.0 with an average HER2 copy number ≥6.0 signals/cell) or amplified by FISH > 2.0. High average copy number of HER2 (≥6.0 signals/cell) is considered positive regardless of the HER2/CEP17 ratio
No prior systemic treatment for metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat metastatic hormone receptor-positive, HER2-positive breast cancer. The goal is to establish the safety and efficacy of this new combination and to examine potential biomarkers of response to the treatment.

Who is the study for?
This trial is for adults with HER2 positive metastatic breast cancer who haven't had systemic treatment for it. They must have certain lab values, be postmenopausal or on ovarian ablation, and agree to use contraception. Excluded are those with severe allergies to similar drugs, uncontrolled medical conditions, recent major surgery or injury, ongoing substance addiction, pregnancy or breastfeeding.Check my eligibility
What is being tested?
The study tests a combination of Anastrozole, Palbociclib (a CDK inhibitor), Trastuzumab and Pertuzumab as first-line therapy in HR-positive, HER2-positive metastatic breast cancer patients. It's designed to assess the safety and effectiveness of this all-biologic regimen while also exploring potential biomarkers that could predict response to treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as infusion-related symptoms; hormonal changes due to Anastrozole; fatigue; blood cell count variations from Palbociclib; heart issues from Trastuzumab and Pertuzumab; plus general risks like nausea and infection susceptibility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is HER2 positive, confirmed by specific tests.
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I have not received any systemic treatment for my metastatic breast cancer.
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I have breast cancer that has spread, including to bones, and it can be measured.
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My breast cancer has spread and shows some hormone receptor positivity.
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I am able to care for myself and perform daily activities.
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I am postmenopausal or receiving treatment to stop my ovaries from working.
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My breast cancer was confirmed through a biopsy.

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
Clinical Benefit Rate (CBR)
Dose-Limiting Toxicity (DLT)
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Incidence of adverse events
Progression Free Survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: HR-positive, Her2-positive Metastatic Breast CancerExperimental Treatment4 Interventions
Women and men with HR-positive, HER2-positive Metastatic Breast Cancer on trial of anastrozole, palbociclib, trastuzumab and pertuzumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved
Anastrozole
FDA approved
Trastuzumab
FDA approved
Pertuzumab
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityOTHER
1,059 Previous Clinical Trials
1,316,099 Total Patients Enrolled
30 Trials studying Breast Cancer
27,182 Patients Enrolled for Breast Cancer
Herbert Irving Comprehensive Cancer CenterOTHER
34 Previous Clinical Trials
1,045 Total Patients Enrolled
5 Trials studying Breast Cancer
320 Patients Enrolled for Breast Cancer
NYU Langone HealthOTHER
1,373 Previous Clinical Trials
841,076 Total Patients Enrolled
38 Trials studying Breast Cancer
7,267 Patients Enrolled for Breast Cancer
~1 spots leftby Jul 2024
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