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NCT03304080 · ClinicalTrials.gov registry record · Phase 1
Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast
A Phase 1 study of Breast Neoplasms and Breast Diseases, sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 5
- Study locations
NCT03304080 is a Phase 1 study of Breast Neoplasms and Breast Diseases that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 44 participants, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 1 state.
The verdict
NCT03304080, a Phase 1 study of Breast Neoplasms and Breast Diseases, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive, HER2-positive breast cancer patients. In this phase I/II clinical trial, the researchers aim to establish the safety and efficacy of dual HER2 therapy in combination with palbociclib and anastrozole, which represents a novel and all biologic approach to the treatment of HR+, HER2+ metastatic breast cancer. Additionally, the researchers aim to examine potential biomarkers of response to palbociclib including cyclin D1, cyclin E1 and cyclin E2 expression levels, CDK 2, 4, and 6 levels, phosphorylated retinoblastoma expression and p16 levels. The researchers intend to use RNA sequencing to assess for other predictors of response in an unbiased manner to see if this correlates with inhibition of Ki-67 and phosphorylated retinoblastoma expression as well as evaluate for potential mechanisms of resistance.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Anastrozole
- DRUG Palbociclib
- DRUG Pertuzumab
Study Locations (5)
New York
- Mount Sinai Beth Israel Comprehensive Cancer Center West - New York
- Perlmutter Cancer Center NYU Langone - New York
- Mount Sinai West - New York
- New York Presbyterian Columbia Irving Comprehensive Cancer Center - New York
- New York Presbyterian Weill Cornell Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-12-20 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03304080
The ClinicalTrials.gov registry entry for NCT03304080 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (92% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.
NCT03304080 reports 5 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03304080 about?
NCT03304080 is a clinical study titled "Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast". This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive, HER2-positive breast cancer patients. In this phase I/II clinical trial, the researchers aim to establish the safety and efficac...
What is the current status of trial NCT03304080?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2017-12-20. Estimated completion is 2026-12-31.
What conditions does trial NCT03304080 study?
This clinical trial studies the following conditions: Breast Neoplasms, Breast Diseases.
What interventions are being tested in trial NCT03304080?
The interventions under investigation include: Trastuzumab (DRUG), Anastrozole (DRUG), Palbociclib (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT03304080?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03304080 being conducted?
This trial has 5 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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