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

Description

To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy.

Study Start Date

August 2014

Estimated Completion Date

October 2015

Interventions

  • Drug: Letrozole
  • Drug: Palbociclib

Specialties

  • Obstetrics & Gynecology: Breast
  • Oncology: Breast
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Hematology/Oncology,Obstetrics/Gynecology

MeSH Terms

  • Breast Neoplasms
  • Palbociclib

Study ID

Pfizer -- A5481034

Status

Available

Trial ID

NCT02142868

Study Type

Expanded Access

Trial Phase

Phase 3

Enrollment Quota

Not Listed

Sponsor

Pfizer

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

Exclusion Criteria

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (68)

Study Location Distance Name Phone Email
ProHealthCARE Associates LLP - Lake Success, New York 39.6 miles None None None
SKCCC at Johns Hopkins Green Spring Station - Lutherville, Maryland 218.1 miles None None None
SKCCC at Johns Hopkins Green Spring Station - Lutherville, Maryland 218.1 miles None None None
SKCCC at Johns Hopkins The Harry and Jeannette Weinberg Building - Baltimore, Maryland 219.6 miles None None None
Mount Nittany Medical Center - State College, Pennsylvania 244.5 miles None None None
Mount Nittany Medical Center - State College, Pennsylvania 244.5 miles None None None
Washington Cancer Institute at MedStar Washington Hospital Center - Washington, District of Columbia 255.3 miles None None None
Washington Cancer Institute at MedStar Washington Hospital Center - Washington, District of Columbia 255.3 miles None None None
MedStar Georgetown University Hospital - Washington, District of Columbia 258.0 miles None None None
Drug Shipment Address Medstar Georgetown University Hospital Research Pharmacy - Washington, District of Columbia 258.0 miles None None None
Medical Oncology Hematology Associates of Northern Virginia Ltd - Reston, Virginia 267.4 miles None None None
Medical Oncology Hematology Associates of Northern Virginia Ltd - Fairfax, Virginia 268.3 miles None None None
UPMC Cancer Center Northwest - Seneca, Pennsylvania 335.9 miles None None None
UPMC Cancer Center Northwest - Seneca, Pennsylvania 335.9 miles None None None
UPMC Cancer Center Arnold Palmer at Mountainview - Greensburg, Pennsylvania 336.1 miles None None None
UPMC Cancer Center Arnold Palmer at Mountainview - Greensburg, Pennsylvania 336.1 miles None None None
UPMC Cancer Center St Margarets - Pittsburgh, Pennsylvania 352.4 miles None None None
University of Pittsburgh Cancer Institute Investigational Drug Service William M Cooper Pavilion - Pittsburgh, Pennsylvania 354.1 miles None None None
University of Pittsburgh Medical Center William M Cooper Pavilion Hillman Cancer Center - Pittsburgh, Pennsylvania 354.1 miles None None None
University of Pittsburgh Cancer Institute Investigational Drug Service William M Cooper Pavilion - Pittsburgh, Pennsylvania 354.1 miles None None None
UPMC Cancer Center Monroeville - Monroeville, Pennsylvania 354.6 miles None None None
MageeWomens Hospital of UPMC - Pittsburgh, Pennsylvania 355.3 miles None None None
UPMC Cancer Center Passavant HOA - Pittsburgh, Pennsylvania 358.1 miles None None None
UPMC Cancer Center Passavant OHA - Pittsburgh, Pennsylvania 358.1 miles None None None
UPMC Cancer Center Greenville - Greenville, Pennsylvania 370.5 miles None None None
UPMC Cancer Center Beaver - Beaver, Pennsylvania 373.2 miles None None None
UPMC Cancer Center Beaver - Beaver, Pennsylvania 373.2 miles None None None
Presence Saint Joseph Hospital - Chicago, Illinois 747.2 miles None None None
Presence Saint Joseph Hospital - Chicago, Illinois 747.2 miles None None None
Presence Infusion Care Skokie - Skokie, Illinois 752.4 miles None None None
Presence Medical Group Hematology Oncology - Northbrook, Illinois 756.8 miles None None None
Presence Medical Group Hematology Oncology - Northbrook, Illinois 756.8 miles None None None
North Shore OncologyHematology Associates Ltd - Libertyville, Illinois 762.4 miles None None None
Gwinnett Hospital System Inc dba The Center for Cancer Care - Lawrenceville, Georgia 773.5 miles None None None
Gwinnett Hospital System Inc dba The Center for Cancer Care - Lawrenceville, Georgia 773.5 miles None None None
Gwinnett Hospital System Inc dba The Center for Cancer Care - Duluth, Georgia 779.8 miles None None None
Gwinnett Hospital System Inc dba The Center for Cancer Care - Duluth, Georgia 779.8 miles None None None
North Shore OncologyHematology Associates Ltd - Crystal Lake, Illinois 781.5 miles None None None
North Shore OncologyHematology Associates Ltd - Crystal Lake, Illinois 781.5 miles None None None
Illinois CancerCare PC - Peoria, Illinois 855.5 miles None None None
Illinois CancerCare PC - Peoria, Illinois 855.5 miles None None None
The West Clinic PC - Corinth, Mississippi 937.2 miles None None None
The West Clinic PC dba West Cancer Center - Memphis, Tennessee 996.2 miles None None None
The West Clinic PC dba West Cancer Center - Memphis, Tennessee 996.2 miles None None None
The West Clinic PC dba West Cancer Center - Germantown, Tennessee 999.8 miles None None None
The West Clinic PC dba West Cancer Center - Memphis, Tennessee 1,002.7 miles None None None
The West Clinic PC dba West Cancer Center - Southaven, Mississippi 1,007.8 miles None None None
The West Clinic PC dba West Cancer Center - Southaven, Mississippi 1,007.8 miles None None None
Jackson Oncology Associates PLLC - Jackson, Mississippi 1,118.9 miles None None None
Jackson Oncology Associates PLLC - Jackson, Mississippi 1,118.9 miles None None None
Jackson Oncology Associates PLLC - Jackson, Mississippi 1,120.8 miles None None None
Mississippi Baptist Health Systems - Jackson, Mississippi 1,120.8 miles None None None
Mississippi Baptist Health Systems - Jackson, Mississippi 1,120.8 miles None None None
Metairie Oncologist LLC - Metairie, Louisiana 1,226.0 miles None None None
Texas Oncology Baylor Charles A Sammons Cancer Center - Dallas, Texas 1,420.1 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,478.4 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,478.4 miles None None None
Swedish Cancer Institute - Seattle, Washington 2,426.6 miles None None None
Swedish Cancer Institute - Seattle, Washington 2,426.6 miles None None None
Northwest Cancer Specialists dba Compass Oncology - Vancouver, Washington 2,458.9 miles None None None
Northwest Cancer Specialists dba Compass Oncology Vancouver Cancer Center - Vancouver, Washington 2,459.9 miles None None None
Northwest Cancer Specialists dba Compass Oncology Vancouver Cancer Center - Vancouver, Washington 2,459.9 miles None None None
Northwest Cancer Specialists dba Compass Oncology East Office - Portland, Oregon 2,463.3 miles None None None
Northwest Cancer Specialists dba Compass Oncology East Office - Portland, Oregon 2,463.3 miles None None None
Northwest Cancer Specialists dba Compass Oncology West Office - Portland, Oregon 2,471.9 miles None None None
Northwest Cancer Specialists dba Compass Oncology West Office - Portland, Oregon 2,471.9 miles None None None
CBCC Global Research Inc at Comprehensive Blood Cancer Center Research Center - Bakersfield, California 2,495.4 miles None None None
CBCC Global Research Inc at Comprehensive Blood Cancer Center Research Center - Bakersfield, California 2,495.4 miles None None None

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