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

NCT02299635

Last updated date
Study Location
Stanford Cancer Institute
Stanford, California, 94305, United States
Contact
1-800-718-1021

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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.

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Triple Negative Breast NeoplasmsA Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations
NCT02299635
  1. Stanford, California
  2. Stanford, California
  3. Stanford, California
  4. Chicago, Illinois
  5. Chicago, Illinois
  6. New Lenox, Illinois
  7. Zion, Illinois
  8. Boston, Massachusetts
  9. Boston, Massachusetts
  10. Basking Ridge, New Jersey
  11. Paramus, New Jersey
  12. Paramus, New Jersey
  13. Westwood, New Jersey
  14. Commack, New York
  15. Harrison, New York
  16. New York, New York
  17. Rockville Centre, New York
  18. Sleepy Hollow, New York
  19. Debrecen,
  20. Lecce,
  21. Milan,
  22. Krakow,
  23. Krakow,
  24. Poznan,
  25. A Coruna,
  26. Barcelona,
  27. Barcelona,
  28. Barcelona,
  29. Barcelona,
  30. Madrid,
  31. Madrid,
  32. Sevilla,
  33. Valencia,
  34. Glasgow, Scotland
  35. Glasgow, Scotland
  36. London,
  37. Surrey,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations
Official Title  ICMJE PHASE 2 STUDY OF SINGLE-AGENT PF-03084014 IN PATIENTS WITH ADVANCED TRIPLE-NEGATIVE BREAST CANCER WITH OR WITHOUT GENOMIC ALTERATIONS IN NOTCH RECEPTORS
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-)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Triple Negative Breast Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
19
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2014)
48
Actual Study Completion Date  ICMJE January 14, 2016
Actual Primary Completion Date January 14, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries France,   Germany
 
Administrative Information
NCT Number  ICMJE NCT02299635
Other Study ID Numbers  ICMJE A8641020
2014-002286-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP