Advanced Breast Cancer (Female) Clinical Trial
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
| NCT number | NCT02142868 |
| Other study ID # | A5481034 |
| Secondary ID | |
| Status | No longer available |
| Phase | |
| First received | |
| Last updated |
| Verified date | December 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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).
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Holy Cross Centre | Calgary | Alberta |
| Canada | Tom Baker Cancer Centre | Calgary | Alberta |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Queen Elizabeth II (QEII) Health Sciences Centre, Nova Scotia Cancer Centre | Halifax | Nova Scotia |
| Canada | London Regional Cancer Program | London | Ontario |
| Canada | McGill University Health Centre (MUHC), Glen Site, Royal Victoria Hospital, Cedars Cancer Centre | Montreal | Quebec |
| Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
| Canada | CHU de Quebec - Hospital du Saint-Sacrement | Quebec | |
| Canada | Sunnybrook health Sciences Centre | Toronto | Ontario |
| Canada | Sunnybrook Odette Cancer Centre | Toronto | Ontario |
| Canada | SunnyBrook Research Institute | Toronto | Ontario |
| United States | CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center | Bakersfield | California |
| United States | SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building | Baltimore | Maryland |
| United States | UPMC Cancer Center Beaver | Beaver | Pennsylvania |
| United States | Presence Saint Joseph Hospital | Chicago | Illinois |
| United States | The West Clinic, P.C. | Corinth | Mississippi |
| United States | North Shore Oncology-Hematology Associates, Ltd. | Crystal Lake | Illinois |
| United States | Texas Oncology -Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care | Duluth | Georgia |
| United States | Medical Oncology & Hematology Associates of Northern Virginia, Ltd. | Fairfax | Virginia |
| United States | The West Clinic, P.C. d/b/a West Cancer Center | Germantown | Tennessee |
| United States | UPMC Cancer Center Arnold Palmer at Mountainview | Greensburg | Pennsylvania |
| United States | UPMC Cancer Center Greenville | Greenville | Pennsylvania |
| United States | Texas Oncology - Memorial City | Houston | Texas |
| United States | Jackson Oncology Associates, PLLC | Jackson | Mississippi |
| United States | Jackson Oncology Associates, PLLC | Jackson | Mississippi |
| United States | Mississippi Baptist Health Systems | Jackson | Mississippi |
| United States | ProHealthCARE Associates, LLP | Lake Success | New York |
| United States | Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care | Lawrenceville | Georgia |
| United States | North Shore Oncology-Hematology Associates, Ltd. | Libertyville | Illinois |
| United States | SKCCC at Johns Hopkins, Green Spring Station | Lutherville | Maryland |
| United States | The West Clinic, P.C. d/b/a West Cancer Center | Memphis | Tennessee |
| United States | The West Clinic, P.C. d/b/a West Cancer Center | Memphis | Tennessee |
| United States | Metairie Oncologist, LLC | Metairie | Louisiana |
| United States | UPMC Cancer Center Monroeville | Monroeville | Pennsylvania |
| United States | Presence Medical Group Hematology Oncology | Northbrook | Illinois |
| United States | Illinois CancerCare, P.C. | Peoria | Illinois |
| United States | Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania |
| United States | University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion | Pittsburgh | Pennsylvania |
| United States | University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center | Pittsburgh | Pennsylvania |
| United States | UPMC Cancer Center Passavant (HOA) | Pittsburgh | Pennsylvania |
| United States | UPMC Cancer Center Passavant (OHA) | Pittsburgh | Pennsylvania |
| United States | UPMC Cancer Center St. Margarets | Pittsburgh | Pennsylvania |
| United States | Northwest Cancer Specialists dba Compass Oncology | Portland | Oregon |
| United States | Northwest Cancer Specialists dba Compass Oncology | Portland | Oregon |
| United States | Medical Oncology & Hematology Associates of Northern Virginia, Ltd. | Reston | Virginia |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | UPMC Cancer Center Northwest | Seneca | Pennsylvania |
| United States | Presence Infusion Care - Skokie | Skokie | Illinois |
| United States | The West Clinic, P.C. d/b/a West Cancer Center | Southaven | Mississippi |
| United States | Mount Nittany Medical Center | State College | Pennsylvania |
| United States | Northwest Cancer Specialists dba Compass Oncology | Vancouver | Washington |
| United States | Northwest Cancer Specialists dba Compass Oncology | Vancouver | Washington |
| United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
| United States | Washington Cancer Institute at MedStar Washington Hospital Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Canada,