NCT00372996|TerminatedPhase 2Results

Study Stopped

This study was closed to enrollment as of 13 May 2011 due to business reasons. Premature closure was not prompted by any safety or efficacy concerns.

Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

A Two-arm Randomized Open Label Phase 2 Study Of Cp-751,871 In Combination With Exemestane Versus Exemestane Alone As First Line Treatment For Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer

Pfizer ClinicalTrials.gov

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2 other identifiers

A40210042006-005573-21

Study Type

interventional

Target

219

Locations

9 countries

Sites

Timeline

RegisteredSep 2006

StartedFeb 2007

CompletionJun 2014

Brief Summary

To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

219

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2007

Longer than P75 for phase_2

Geographic Reach

9 countries

62 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.3 years study duration

First Submitted

Initial submission to the registry

September 5, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed

5 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 28, 2015

Completed

Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

5.6 years

First QC Date

September 5, 2006

Results QC Date

June 3, 2015

Last Update Submit

October 6, 2015

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

Progression-Free Survival (PFS)
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent \[%\] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.
Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.
Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months

Secondary Outcomes (9)

Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months
Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
Maximum Plasma Concentration of CP-751,871
Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
Minimum Plasma Concentration of CP-751,871
Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration
Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871
Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)
Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion
+4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

CP-751,871 + exemestane Treatment until progression or toxicity

Drug: CP-751,871Drug: exemestaneDrug: Fulvestrant

2

ACTIVE COMPARATOR

Drug: exemestane

Interventions

CP-751,871DRUG

CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.

exemestaneDRUG

Exemestane given at 25 mg orally once a day.

FulvestrantDRUG

Used for salvage therapy and administered according to the local label and standard clinical practice.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer
HbA1c \<5.7%

You may not qualify if:

Previous treatment for advanced disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (62)

UCSD Medical Center - La Jolla

La Jolla, California, 92037, United States

Location

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

UCSD Medical Center - Hillcrest

San Diego, California, 92103, United States

Location

Washington Cancer Institute (WCI) at Washington Hospital Center (WHC)

Washington D.C., District of Columbia, 20010-3017, United States

Location

Florida Cancer Research Institute

Davie, Florida, 33328, United States

Location

Florida Cancer Research Institute

Plantation, Florida, 33324, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Lexington Oncology Associates

Lexington, Kentucky, 40503, United States

Location

Bluegrass Hematology/Oncology, PSC

Lexington, Kentucky, 40504, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Bringham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 2215, United States

Location

University of Minnesota Medical Center-Fairview, Riverside Campus

Minneapolis, Minnesota, 55454, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

University Of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Alamance Regional Medical Center - Cancer Center

Burlington, North Carolina, 27215-8700, United States

Location

Duke University Medical Center - Morris Cancer Center Clinics