search
Back to results

Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

Primary Purpose

Advanced Breast Cancer (Female)

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Palbociclib
Letrozole
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Advanced Breast Cancer (Female) focused on measuring Expanded Access, Advanced Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
  • ER-positive and/or PR-positive tumor based on local laboratory results
  • HER2-negative tumor based on local laboratory results
  • Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)

Exclusion Criteria:

  • Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor

Sites / Locations

  • CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center
  • MedStar Georgetown University Hospital
  • Washington Cancer Institute at MedStar Washington Hospital Center
  • Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
  • Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
  • Presence Saint Joseph Hospital
  • North Shore Oncology-Hematology Associates, Ltd.
  • North Shore Oncology-Hematology Associates, Ltd.
  • Presence Medical Group Hematology Oncology
  • Illinois CancerCare, P.C.
  • Presence Infusion Care - Skokie
  • Metairie Oncologist, LLC
  • SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building
  • SKCCC at Johns Hopkins, Green Spring Station
  • The West Clinic, P.C.
  • Jackson Oncology Associates, PLLC
  • Mississippi Baptist Health Systems
  • Jackson Oncology Associates, PLLC
  • The West Clinic, P.C. d/b/a West Cancer Center
  • ProHealthCARE Associates, LLP
  • Northwest Cancer Specialists dba Compass Oncology
  • Northwest Cancer Specialists dba Compass Oncology
  • UPMC Cancer Center Beaver
  • UPMC Cancer Center Arnold Palmer at Mountainview
  • UPMC Cancer Center Greenville
  • UPMC Cancer Center Monroeville
  • Magee-Womens Hospital of UPMC
  • UPMC Cancer Center St. Margarets
  • University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion
  • University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
  • UPMC Cancer Center Passavant (HOA)
  • UPMC Cancer Center Passavant (OHA)
  • UPMC Cancer Center Northwest
  • Mount Nittany Medical Center
  • The West Clinic, P.C. d/b/a West Cancer Center
  • The West Clinic, P.C. d/b/a West Cancer Center
  • The West Clinic, P.C. d/b/a West Cancer Center
  • Texas Oncology -Baylor Charles A. Sammons Cancer Center
  • Texas Oncology - Memorial City
  • Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
  • Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
  • Swedish Cancer Institute
  • Northwest Cancer Specialists dba Compass Oncology
  • Northwest Cancer Specialists dba Compass Oncology
  • Tom Baker Cancer Centre
  • Holy Cross Centre
  • Cross Cancer Institute
  • Queen Elizabeth II (QEII) Health Sciences Centre, Nova Scotia Cancer Centre
  • London Regional Cancer Program
  • The Ottawa Hospital Cancer Centre
  • Sunnybrook health Sciences Centre
  • Sunnybrook Odette Cancer Centre
  • SunnyBrook Research Institute
  • McGill University Health Centre (MUHC), Glen Site, Royal Victoria Hospital, Cedars Cancer Centre
  • CHU de Quebec - Hospital du Saint-Sacrement

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 16, 2014
Last Updated
December 20, 2018
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT02142868
Brief Title
Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate
Official Title
AN EXPANDED ACCESS STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE
Study Type
Expanded Access

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).
Detailed Description
This study is currently available in Canada only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer (Female)
Keywords
Expanded Access, Advanced Breast Cancer

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Palbociclib
Other Intervention Name(s)
Ibrance
Intervention Description
Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1)
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease) ER-positive and/or PR-positive tumor based on local laboratory results HER2-negative tumor based on local laboratory results Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only) Exclusion Criteria: Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Washington Cancer Institute at MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Presence Saint Joseph Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
North Shore Oncology-Hematology Associates, Ltd.
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60014
Country
United States
Facility Name
North Shore Oncology-Hematology Associates, Ltd.
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Presence Medical Group Hematology Oncology
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Illinois CancerCare, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Presence Infusion Care - Skokie
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Metairie Oncologist, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
SKCCC at Johns Hopkins, Green Spring Station
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
The West Clinic, P.C.
City
Corinth
State/Province
Mississippi
ZIP/Postal Code
38834
Country
United States
Facility Name
Jackson Oncology Associates, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Mississippi Baptist Health Systems
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Jackson Oncology Associates, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
The West Clinic, P.C. d/b/a West Cancer Center
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
ProHealthCARE Associates, LLP
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Northwest Cancer Specialists dba Compass Oncology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Northwest Cancer Specialists dba Compass Oncology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
UPMC Cancer Center Beaver
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
UPMC Cancer Center Arnold Palmer at Mountainview
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
UPMC Cancer Center Greenville
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Facility Name
UPMC Cancer Center Monroeville
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Cancer Center St. Margarets
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Facility Name
University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Cancer Center Passavant (HOA)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
UPMC Cancer Center Passavant (OHA)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
UPMC Cancer Center Northwest
City
Seneca
State/Province
Pennsylvania
ZIP/Postal Code
16346
Country
United States
Facility Name
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
The West Clinic, P.C. d/b/a West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The West Clinic, P.C. d/b/a West Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
The West Clinic, P.C. d/b/a West Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Oncology -Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Northwest Cancer Specialists dba Compass Oncology
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98683
Country
United States
Facility Name
Northwest Cancer Specialists dba Compass Oncology
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Holy Cross Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3C3
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Queen Elizabeth II (QEII) Health Sciences Centre, Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
SunnyBrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University Health Centre (MUHC), Glen Site, Royal Victoria Hospital, Cedars Cancer Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHU de Quebec - Hospital du Saint-Sacrement
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

We'll reach out to this number within 24 hrs