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A Study of PD-0332991 + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01740427
First received: November 26, 2012
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.


Condition Intervention Phase
Breast Neoplasms
 Drug: PD-0332991
Drug: Letrozole
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind Phase 3 Study Of PD-0332991 (Oral CDK 4/6 Inhibitor) Plus Letrozole Versus Placebo Plus Letrozole For The Treatment Of Postmenopausal Women With ER (+), HER2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti Cancer Treatment For Advanced Disease

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Probability of Participant Survival [ Time Frame: From start of study treatment up to 6 years ] [ Designated as safety issue: Yes ]
  • Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to 6 years) ] [ Designated as safety issue: Yes ]
  • Objective Response (OR) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • Disease Control (DC) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • QTc interval [ Time Frame: Baseline and Day 14 of Cycle 1 ] [ Designated as safety issue: Yes ]
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Day 14 of cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week X [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • Change From Baseline in Functional Assessment od Cancer therapy -Breast (FACT-B) at Week X [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
  • Tumor tissue biomarkers [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD-0332991 + Letrozole
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
 Drug: PD-0332991
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Drug: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
Active Comparator: Placebo + Letrozole
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
 Drug: Placebo
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Drug: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)

  Eligibility

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

Inclusion Criteria:

  • Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.
  • Confirmed diagnosis of ER positive breast cancer
  • No prior systemic anti-cancer therapy for advanced ER+ disease.
  • Postmenopausal women
  • Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease
  • Eastern Cooperative Oncology Group [ECOG] 0-2
  • Adequate organ and marrow function
  • Patient must agree to provide tumor tissue

Exclusion Criteria:

  • Confirmed diagnosis of HER2 positive disease
  • Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
  • Known uncontrolled or symptomatic CNS metastases
  • Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
  • Prior treatment with any CDK 4/6 inhibitor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740427

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com

Locations
United States, California
Pfizer Investigational Site Not yet recruiting
Beverly Hills, California, United States, 90211
Pfizer Investigational Site Recruiting
Fullerton, California, United States, 92835
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90095
Pfizer Investigational Site Recruiting
Redondo Beach, California, United States, 90277
Pfizer Investigational Site Recruiting
San Francisco, California, United States, 94115
Pfizer Investigational Site Recruiting
San Luis Obispo, California, United States, 93401
Pfizer Investigational Site Recruiting
Santa Maria, California, United States, 93454
United States, Colorado
Pfizer Investigational Site Recruiting
Grand Junction, Colorado, United States, 81501
United States, Florida
Pfizer Investigational Site Recruiting
Hollywood, Florida, United States, 33021
Pfizer Investigational Site Recruiting
Jacksonville, Florida, United States, 32256
United States, Georgia
Pfizer Investigational Site Recruiting
Lawrenceville, Georgia, United States, 30046
United States, Nevada
Pfizer Investigational Site Not yet recruiting
Las Vegas, Nevada, United States, 89169
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01740427     History of Changes
Other Study ID Numbers: A5481008
Study First Received: November 26, 2012
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
breast cancer
postmenopausal women
estrogen-receptor positive
 HER2 negative
locoregionally recurrent
metastatic

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

ClinicalTrials.gov processed this record on May 23, 2013