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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityOTHER

1,054 Previous Clinical Trials

1,316,484 Total Patients Enrolled

30 Trials studying Breast Cancer

27,216 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

1,367 Previous Clinical Trials

839,677 Total Patients Enrolled

38 Trials studying Breast Cancer

7,267 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Palbociclib undergone extensive testing in the medical community?

"There are 377 active clinical trials and 88 phase 3 trials currently underway for Palbociclib. Most of these studies originate from Seattle, Washington; however, there are 26621 locations globally where research is being conducted."

Answered by AI

How many people are enrolled in this research project?

"Unfortunately, this particular trial is no longer enrolling patients. Although, it was originally posted on December 20th, 2017 and last updated on October 5th, 2022. There are presently 2378 clinical trials actively recruiting participants with breast diseases and 377 studies for Palbociclib admitting participants."

Answered by AI

What is the most popular indication for Palbociclib?

"Palbociclib is a medication used to target the brca1 gene. It can also help patients with breast cancer, inflammatory breast cancer (ibc), and those that have undergone 2-3 years of tamoxifen therapy."

Answered by AI

Are people currently signing up to participate in this experiment?

"Unfortunately, this particular trial is not currently recruiting patients. Although, it is worth mentioning that there are nearly 3000 other active clinical trials searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast

Amy Tiersten 2017. "Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03304080.

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