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

Stopped early · Phase 2

Conditions studied: Triple Negative Breast Neoplasms

In brief

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-)

Key facts

Study ID

NCT02299635

Run by

Pfizer

People needed

19

Starts

2015-02-03

Expected to finish

2016-01-14

Last updated by the study team

2019-01-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known brain metastases.
• Prior treatment with gamma secretase inhibitor or other Notch signaling inhibitor.

Where it is running

• Stanford Cancer Institute — Stanford, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Stanford Women's Cancer Center — Stanford, California, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center at Silver Cross Hospital — New Lenox, Illinois, United States
• Midwestern Regional Medical Center — Zion, Illinois, United States
• Brigham and Women's Hospital (BWH) — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center Basking Ridge — Basking Ridge, New Jersey, United States
• The Valley Hospital - Luckow Pavilion — Paramus, New Jersey, United States
• Valley Medical Group — Paramus, New Jersey, United States
• Valley Medical Group — Westwood, New Jersey, United States
• Memorial Sloan Kettering Cancer Center Commack — Commack, New York, United States
• Memorial Sloan Kettering Cancer Center West Harrison — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center Rockville Centre — Rockville Centre, New York, United States
• Memorial Sloan Kettering Cancer Center Sleepy Hollow — Sleepy Hollow, New York, United States
• Debreceni Egyetem, Klinikai Kozpont, Onkologiai Intezet — Debrecen, Hungary
• Presidio Ospedaliero Vito Fazzi — Lecce, Italy
• Istitutio Europeo di Oncologia — Milan, Italy
• Vesalius — Krakow, Poland
• Vesalius Poradnia Onkologiczna i Hematologiczna — Krakow, Poland
• Szpital Kliniczny Przemienienia Panskiego, Uniwersutetu Medycznego im. Karola Marcinkowskiego — Poznan, Poland
• Complejo Hospitalario Universitario A Coruna (Hospital Teresa Herrera) — A Coruña, Spain

Full record on ClinicalTrials.gov

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