A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations

NCT ID: NCT02299635

Last Updated: 2019-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-03

Study Completion Date

2016-01-14

Brief Summary

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This study is designed to evaluate the preliminary anti-tumor activity and tolerability of PF-03084014 when administered as a single agent in the treatment of patients with advanced triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for genomic alterations in Notch receptors (NA-)

Detailed Description

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Conditions

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Triple Negative Breast Neoplasms

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-03084014

PF-03084014 will be administered orally, continuously, twice daily at 150 mg, but the dose can be reduced to 100 mg or 80 mg.

Group Type EXPERIMENTAL

PF-03084014

Intervention Type DRUG

Tablet, 10 mg, twice a day.

PF-03084014

Intervention Type DRUG

Tablet, 50 mg, twice a day

PF-03084014

Intervention Type DRUG

Tablet, 100 mg, twice a day

Interventions

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PF-03084014

Tablet, 10 mg, twice a day.

Intervention Type DRUG

PF-03084014

Tablet, 50 mg, twice a day

Intervention Type DRUG

PF-03084014

Tablet, 100 mg, twice a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological diagnosis of triple negative breast cancer (TNBC) with evidence of a) metastatic or b) locally recurrent advanced disease that is not amenable to resection or radiotherapy with curative intent.
* Availability of an original diagnostic tumor tissue or the most recent metastatic tumor biopsies (archival biopsy or de novo biopsy) and a peripheral blood sample for Notch receptors genomic profiling

Exclusion Criteria

* Known brain metastases.
* Prior treatment with gamma secretase inhibitor or other Notch signaling inhibitor.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Stanford Cancer Institute

Stanford, California, United States

Site Status

Stanford Hospital and Clinics

Stanford, California, United States

Site Status

Stanford Women's Cancer Center

Stanford, California, United States

Site Status

The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States

Site Status

Midwestern Regional Medical Center

Zion, Illinois, United States

Site Status

Brigham and Women's Hospital (BWH)

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, United States

Site Status

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, United States

Site Status

Valley Medical Group

Paramus, New Jersey, United States

Site Status

Valley Medical Group

Westwood, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center West Harrison

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center Rockville Centre

Rockville Centre, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center Sleepy Hollow

Sleepy Hollow, New York, United States

Site Status

Debreceni Egyetem, Klinikai Kozpont, Onkologiai Intezet

Debrecen, , Hungary

Site Status

Presidio Ospedaliero Vito Fazzi

Lecce, , Italy

Site Status

Istitutio Europeo di Oncologia

Milan, , Italy

Site Status

Vesalius

Krakow, , Poland

Site Status

Vesalius Poradnia Onkologiczna i Hematologiczna

Krakow, , Poland

Site Status

Szpital Kliniczny Przemienienia Panskiego, Uniwersutetu Medycznego im. Karola Marcinkowskiego

Poznan, , Poland

Site Status

Complejo Hospitalario Universitario A Coruna (Hospital Teresa Herrera)

A Coruña, , Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Instituto Catalan de Oncologia de L'Hospitalet de Llobregat (ICO)

Barcelona, , Spain

Site Status

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

Site Status

Ross Hall Hospital

Glasgow, Scotland, United Kingdom

Site Status

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status

The Royal Marsden NHS Foundation Trust

Surrey, , United Kingdom

Site Status

Countries

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United States Hungary Italy Poland Spain United Kingdom

Related Links

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Other Identifiers

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2014-002286-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A8641020

Identifier Type: -

Identifier Source: org_study_id

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