You are here

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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Stanford Cancer Institute
Stanford, California, 94305 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Triple Negative Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Known brain metastases.

- Prior treatment with gamma secretase inhibitor or other Notch signaling inhibitor.

NCT02299635
Pfizer
Terminated
A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations
Phase 2 Study Of Single-agent Pf-03084014 In Patients With Advanced Triple-negative Breast Cancer With Or Without Genomic Alterations In Notch Receptors
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-)
Not Provided
Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Triple Negative Breast Neoplasms
  • Drug: PF-03084014
    Tablet, 10 mg, twice a day.
  • Drug: PF-03084014
    Tablet, 50 mg, twice a day
  • Drug: PF-03084014
    Tablet, 100 mg, twice a day
Experimental: 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.
Interventions:
  • Drug: PF-03084014
  • Drug: PF-03084014
  • Drug: PF-03084014
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
January 2016
January 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   Italy,   Poland,   Spain,   United Kingdom,   United States
France,   Germany
 
NCT02299635
A8641020
2014-002286-30 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now