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
Sponsor
Pfizer (Industry)
Overall Status
No longer available
CT.gov ID
NCT02142868
Collaborator
(none)
55
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
This study is currently available in Canada only.
Study Design
Study Type:
Expanded Access
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
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center | Bakersfield | California | United States | 93309 |
| 2 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 3 | Washington Cancer Institute at MedStar Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 4 | Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care | Duluth | Georgia | United States | 30096 |
| 5 | Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care | Lawrenceville | Georgia | United States | 30046 |
| 6 | Presence Saint Joseph Hospital | Chicago | Illinois | United States | 60657 |
| 7 | North Shore Oncology-Hematology Associates, Ltd. | Crystal Lake | Illinois | United States | 60014 |
| 8 | North Shore Oncology-Hematology Associates, Ltd. | Libertyville | Illinois | United States | 60048 |
| 9 | Presence Medical Group Hematology Oncology | Northbrook | Illinois | United States | 60062 |
| 10 | Illinois CancerCare, P.C. | Peoria | Illinois | United States | 61615 |
| 11 | Presence Infusion Care - Skokie | Skokie | Illinois | United States | 60077 |
| 12 | Metairie Oncologist, LLC | Metairie | Louisiana | United States | 70006 |
| 13 | SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building | Baltimore | Maryland | United States | 21287 |
| 14 | SKCCC at Johns Hopkins, Green Spring Station | Lutherville | Maryland | United States | 21093 |
| 15 | The West Clinic, P.C. | Corinth | Mississippi | United States | 38834 |
| 16 | Jackson Oncology Associates, PLLC | Jackson | Mississippi | United States | 39202 |
| 17 | Mississippi Baptist Health Systems | Jackson | Mississippi | United States | 39202 |
| 18 | Jackson Oncology Associates, PLLC | Jackson | Mississippi | United States | 39216 |
| 19 | The West Clinic, P.C. d/b/a West Cancer Center | Southaven | Mississippi | United States | 38671 |
| 20 | ProHealthCARE Associates, LLP | Lake Success | New York | United States | 11042 |
| 21 | Northwest Cancer Specialists dba Compass Oncology | Portland | Oregon | United States | 97213 |
| 22 | Northwest Cancer Specialists dba Compass Oncology | Portland | Oregon | United States | 97225 |
| 23 | UPMC Cancer Center Beaver | Beaver | Pennsylvania | United States | 15009 |
| 24 | UPMC Cancer Center Arnold Palmer at Mountainview | Greensburg | Pennsylvania | United States | 15601 |
| 25 | UPMC Cancer Center Greenville | Greenville | Pennsylvania | United States | 16125 |
| 26 | UPMC Cancer Center Monroeville | Monroeville | Pennsylvania | United States | 15146 |
| 27 | Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
| 28 | UPMC Cancer Center St. Margarets | Pittsburgh | Pennsylvania | United States | 15215 |
| 29 | University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion | Pittsburgh | Pennsylvania | United States | 15232 |
| 30 | University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 31 | UPMC Cancer Center Passavant (HOA) | Pittsburgh | Pennsylvania | United States | 15237 |
| 32 | UPMC Cancer Center Passavant (OHA) | Pittsburgh | Pennsylvania | United States | 15237 |
| 33 | UPMC Cancer Center Northwest | Seneca | Pennsylvania | United States | 16346 |
| 34 | Mount Nittany Medical Center | State College | Pennsylvania | United States | 16803 |
| 35 | The West Clinic, P.C. d/b/a West Cancer Center | Germantown | Tennessee | United States | 38138 |
| 36 | The West Clinic, P.C. d/b/a West Cancer Center | Memphis | Tennessee | United States | 38104 |
| 37 | The West Clinic, P.C. d/b/a West Cancer Center | Memphis | Tennessee | United States | 38120 |
| 38 | Texas Oncology -Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 39 | Texas Oncology - Memorial City | Houston | Texas | United States | 77024 |
| 40 | Medical Oncology & Hematology Associates of Northern Virginia, Ltd. | Fairfax | Virginia | United States | 22031 |
| 41 | Medical Oncology & Hematology Associates of Northern Virginia, Ltd. | Reston | Virginia | United States | 20190 |
| 42 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
| 43 | Northwest Cancer Specialists dba Compass Oncology | Vancouver | Washington | United States | 98683 |
| 44 | Northwest Cancer Specialists dba Compass Oncology | Vancouver | Washington | United States | 98684 |
| 45 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 46 | Holy Cross Centre | Calgary | Alberta | Canada | T2S 3C3 |
| 47 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 48 | Queen Elizabeth II (QEII) Health Sciences Centre, Nova Scotia Cancer Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 49 | London Regional Cancer Program | London | Ontario | Canada | N6A 4L6 |
| 50 | The Ottawa Hospital Cancer Centre | Ottawa | Ontario | Canada | K1H 8L6 |
| 51 | Sunnybrook health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 52 | Sunnybrook Odette Cancer Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 53 | SunnyBrook Research Institute | Toronto | Ontario | Canada | M4N 3M5 |
| 54 | McGill University Health Centre (MUHC), Glen Site, Royal Victoria Hospital, Cedars Cancer Centre | Montreal | Quebec | Canada | H4A 3J1 |
| 55 | CHU de Quebec - Hospital du Saint-Sacrement | Quebec | Canada | G1S 4L8 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02142868
Other Study ID Numbers:
- A5481034
First Posted:
May 20, 2014
Last Update Posted:
Dec 21, 2018
Last Verified:
Dec 1, 2018
Keywords provided by Pfizer
Additional relevant MeSH terms: