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

NCT02299635 | Terminated Phase 2 Results

• 2 other identifiers: A86410202014-002286-30
• Study Type: interventional
• Target: 19
• Locations: 6 countries
• Sites: 37

Brief Summary

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-)

Conditions

Triple Negative Breast Neoplasms

Keywords

PF-03084014; Notch Alterations

Outcome Measures

Primary Outcomes (1)

• Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+)

  OR status based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis less than \[\<\]10 millimeter \[mm\]). PR: Greater than or equal to (\>=)30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR.

  Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.

Secondary Outcomes (15)

• OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-)

  Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.

• Progression-Free Survival (PFS) in Participants With NA+ or NA mTNBC

  2 years

• Duration of Response (DR) in Participants With NA+ or NA mTNBC

  2 years

• One-Year Survival Probability in Participants With NA+ or NA mTNBC

  1 year

• Overall Survival (OS) in Participants With NA+ or NA mTNBC

  2 years

Study Arms (1)

PF-03084014

EXPERIMENTAL

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

Drug: PF-03084014

Interventions

PF-03084014 DRUG

Tablet, 10 mg, twice a day.

PF-03084014

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (37)

Stanford Cancer Institute

Stanford, California, 94305, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Stanford Women's Cancer Center

Stanford, California, 94305, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, 60451, United States

Location

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

Brigham and Women's Hospital (BWH)

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, 07652, United States

Location

Valley Medical Group

Paramus, New Jersey, 07652, United States

Location

Valley Medical Group

Westwood, New Jersey, 07675, United States

Location

Memorial Sloan Kettering Cancer Center Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center West Harrison

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Cancer Center Sleepy Hollow

Sleepy Hollow, New York, 10591, United States

Location

Debreceni Egyetem, Klinikai Kozpont, Onkologiai Intezet

Debrecen, 4032, Hungary

Location

Presidio Ospedaliero Vito Fazzi

Lecce, 73100, Italy

Location

Istitutio Europeo di Oncologia

Milan, 20141, Italy

Location

Vesalius

Krakow, 31108, Poland

Location

Vesalius Poradnia Onkologiczna i Hematologiczna

Krakow, 31216, Poland

Location

Szpital Kliniczny Przemienienia Panskiego, Uniwersutetu Medycznego im. Karola Marcinkowskiego

Poznan, 60-569, Poland

Location

Complejo Hospitalario Universitario A Coruna (Hospital Teresa Herrera)

A Coruña, 15006, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

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

Barcelona, 08908, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Ross Hall Hospital

Glasgow, Scotland, G52 3NQ, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Surrey, SM2 5PT, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

nirogacestat

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

This study was terminated prematurely based on project re-prioritization by the Sponsor and was not due to any safety concerns or regulatory actions.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: February 3, 2015
• Primary Completion: January 14, 2016
• Study Completion: January 14, 2016
• Last Updated: January 8, 2019
• Results First Posted: January 13, 2017

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

HU (1); IT (2); PL (3); ES (9); US (18); GB (4)