Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00721409
First received: July 22, 2008
Last updated: October 11, 2014
Last verified: October 2014
  Purpose

The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer


Condition Intervention Phase
Breast Cancer
Drug: PD 0332991
Drug: letrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2, Open-label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Letrozole Plus Pd 0332991 (Oral Cdk 4/6 Inhibitor) And Letrozole Single Agent For The First-line Treatment Of Er Positive, Her2 Negative Advanced Breast Cancer In Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Phase 1 : overall safety profile of PD 0332991 in combination with letrozole [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
  • Phase 2 : progression-free survival [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase 2: antitumor activity, overall survival, patient reported outcome of pain, tumor tissue biomarkers, selected gene polymorphism [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
  • Phase 2: overall safety profile [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
  • Phase 1: pharmacokinetics, QTc, antitumor activity, tumor tissue biomarkers, selected gene polymorphism [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 228
Study Start Date: September 2008
Estimated Study Completion Date: July 2018
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
letrozole + PD 0332991
Drug: PD 0332991
125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles
Drug: letrozole
2.5 mg/d tablets orally on a continuous regimen
Active Comparator: Arm B
letrozole
Drug: letrozole
2.5 mg/d tablets orally on a continuous regimen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inoperable estrogen receptor positive and HER2 negative breast cancer.
  • Postmenopausal status.
  • Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.
  • Acceptable bone marrow, liver and kidney function.

Exclusion Criteria:

  • Prior or concomitant treatment for advanced breast cancer.
  • Other major cancer in the past 3 years.
  • Important cardiovascular events in the past 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721409

  Show 109 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00721409     History of Changes
Other Study ID Numbers: A5481003, 2008-002392-27
Study First Received: July 22, 2008
Last Updated: October 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
hormone-receptor positive advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014