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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
Must not have
Co-administration with specific medications
HER2 negative metastatic breast carcinoma defined as 0 or 1+ by IHC or with a FISH ratio (HER2 gene copy/ chromosome 17) <2 if IHC 2+ by local institution standard protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking certain medications along with my treatment.
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My breast cancer is HER2 negative based on specific tests.
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My cancer has spread to the lining of my brain and spinal cord.
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I have brain metastases that are not under control.
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I have received treatment for breast cancer that has spread.
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I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Benefit Rate (CBR)
Dose-Limiting Toxicity (DLT)
Maximum Tolerated Dose (MTD)
Secondary study objectives
Incidence of adverse events
Progression Free Survival

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: 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
Trastuzumab
FDA approved
Pertuzumab
FDA approved
Anastrozole
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityOTHER
1,081 Previous Clinical Trials
1,137,995 Total Patients Enrolled
30 Trials studying Breast Cancer
27,181 Patients Enrolled for Breast Cancer
Herbert Irving Comprehensive Cancer CenterOTHER
35 Previous Clinical Trials
1,277 Total Patients Enrolled
5 Trials studying Breast Cancer
320 Patients Enrolled for Breast Cancer
NYU Langone HealthOTHER
1,403 Previous Clinical Trials
855,082 Total Patients Enrolled
38 Trials studying Breast Cancer
7,424 Patients Enrolled for Breast Cancer
~4 spots leftby Jul 2025
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