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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Triple Negative Breast Neoplasms

Treatments: Drug: PF-03084014

Study type: Interventional

Funder types: Industry

Identifiers

NCT02299635

2014-002286-30 (EudraCT Number)

A8641020

Details and patient eligibility

About

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-)

Enrollment: 19 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

19 participants in 1 patient group

PF-03084014

Experimental group

Description:

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

Treatment:

Drug: PF-03084014

Drug: PF-03084014

Drug: PF-03084014