ClinicalTrials.gov record
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
ClinicalTrials.gov ID: NCT01942135
Public ClinicalTrials.gov record NCT01942135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).
Study identification
- NCT ID
- NCT01942135
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 521 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 26, 2013 (Actual)
- Primary completion
- Dec 5, 2014 (Actual)
- Completion
- Sep 28, 2022 (Actual)
- Last update posted
- Apr 4, 2024
2013 – 2022
United States locations
- U.S. sites
- 134
- U.S. states
- 23
- U.S. cities
- 93
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham, The Kirklin Clinic | Birmingham | Alabama | 35233 | — |
| UAB Hospital-Investigational Drug Service | Birmingham | Alabama | 35249 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| Southern Cancer Center, PC | Daphne | Alabama | 36526 | — |
| Southern Cancer Center, PC | Mobile | Alabama | 36607 | — |
| Southern Cancer Center, PC | Mobile | Alabama | 36608 | — |
| Southern Cancer Center,PC | Mobile | Alabama | 36608 | — |
| Arizona Center for Cancer Care | Avondale | Arizona | 85323 | — |
| Ironwood Physicians P.C dba Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | — |
| Arizona Oncology Associates, PC- HAL | Flagstaff | Arizona | 86001 | — |
| Ironwood Physicians P.C dba Ironwood Cancer & Research Centers | Gilbert | Arizona | 85297 | — |
| Palo Verde Hematology Oncology | Glendale | Arizona | 85304 | — |
| Arizona Center for Cancer Care | Glendale | Arizona | 85306 | — |
| Western Regional Medical Center, Inc. | Goodyear | Arizona | 85338 | — |
| Ironwood Physicians P.C dba Ironwood Cancer & Research Centers | Mesa | Arizona | 85202 | — |
| Ironwood Physicians P.C dba Ironwood Cancer & Research Centers | Mesa | Arizona | 85206 | — |
| Arizona Oncology Associates, PC- HAL | Prescott Valley | Arizona | 86314 | — |
| Arizona Oncology Associates, PC- HAL | Sedona | Arizona | 86336 | — |
| Arizona Center for Cancer Care | Surprise | Arizona | 85374 | — |
| The University of Arizona Cancer Center- North Campus | Tucson | Arizona | 85719 | — |
| The University of Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| CBCC Global Research Inc. at Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | — |
| Administrative Management Only: Translational Research Management | Culver City | California | 90232 | — |
| City of Hope | Duarte | California | 91010 | — |
| St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare | Fullerton | California | 92835 | — |
| Global Research Management | Glendale | California | 91204 | — |
| UC San Diego Medical Center-La Jolla | La Jolla | California | 92037 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
| LAC & USC Medical Center | Los Angeles | California | 90033 | — |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UCLA Hematology Oncology | Los Angeles | California | 90095 | — |
| Breastlink Medical Group, Inc. | Orange | California | 92868 | — |
| Hematology Oncology Medical Group of Orange County, Inc. (HOMG) | Orange | California | 92868 | — |
| The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange | Orange | California | 92868 | — |
| UCLA Hematology/Oncology - Pasadena | Pasadena | California | 91105 | — |
| UC San Diego Medical Center-Hillcrest | San Diego | California | 92103 | — |
| University of California, San Francisco: Helen Diller Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers | San Luis Obispo | California | 93401 | — |
| Breastlink Medical Group, Inc. | Santa Ana | California | 92705 | — |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | — |
| UCLA Hematology/Oncology - Santa Monica | Santa Monica | California | 90404 | — |
| City of Hope | South Pasadena | California | 91030 | — |
| Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates | Torrance | California | 90505 | — |
| Torrance Memorial Physician Network-Cancer Care | Torrance | California | 90505 | — |
| Wellness Oncology & Hematology | West Hills | California | 91307 | — |
| UCLA Hematology - Oncology Clinic - Westlake Village | Westlake Village | California | 91361 | — |
| ATTN - Research Pharmacist | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) | Aurora | Colorado | 80045 | — |
| Mount Sinai Medical Center- Aventura | Aventura | Florida | 33180 | — |
| Sylvester Comprehensive Cancer Center Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| University of Miami Hospitals and Clinics (UHMC) Sylvester at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida | 33308 | — |
| Memorial Breast Cancer Center at Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| University of Miami Hospitals & Clinics | Miami | Florida | 33136 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Orlando Health | Ocoee | Florida | 34761 | — |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | — |
| Memorial Breast Cancer Center at Memorial Hospital West | Pembroke Pines | Florida | 33028 | — |
| Memorial Cancer Institute at Memorial Hospital West | Pembroke Pines | Florida | 33028 | — |
| Memorial Hospital West | Pembroke Pines | Florida | 33028 | — |
| Sylvester at Plantation | Plantation | Florida | 33324 | — |
| Piedmont Cancer Institute, PC | Atlanta | Georgia | 30318 | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Austell | Georgia | 30106 | — |
| Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital | Cartersville | Georgia | 30121 | — |
| Piedmont Cancer Institute, PC | Fayetteville | Georgia | 30214 | — |
| Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital | Marietta | Georgia | 30060 | — |
| Northwest Georgia Oncology Centers, PC | Marietta | Georgia | 30060 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Cancer Treatment Centers of America at Midwestern Regional Medical Center | Zion | Illinois | 60099 | — |
| Maine Center for Cancer Medicine, dba: New England Cancer Specialists | Brunswick | Maine | 04011 | — |
| Maine Center for Cancer Medicine, dba: New England Cancer Specialists | Kennebunk | Maine | 04043 | — |
| Maine Center for Cancer Medicine, dba: New England Cancer Specialists | Scarborough | Maine | 04074 | — |
| Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins | Baltimore | Maryland | 21231 | — |
| Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station | Lutherville | Maryland | 21093 | — |
| University of Michigan Health System/Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | — |
| Fairview Southdale Oncology Clinic | Edina | Minnesota | 55435 | — |
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | — |
| University of Minnesota Physicians, Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mercy Clinic St. Louis Cancer and Breast Institute | Ballwin | Missouri | 63011 | — |
| Mercy Ministry Office | Chesterfield | Missouri | 63017 | — |
| Mercy Clinic St. Louis Cancer and Breast Institute | St Louis | Missouri | 63109 | — |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | — |
| Mercy Hospital St.Louis- David C. Pratt Cancer Center | St Louis | Missouri | 63141 | — |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052 | — |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89052 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| CareMount Medical | Brewster | New York | 10509 | — |
| ProHEALTHCARE Associates, LLP | Lake Success | New York | 11042 | — |
| CareMount Medical | Mount Kisco | New York | 10549 | — |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | — |
| Hope Women's Cancer Centers | Asheville | North Carolina | 28806 | — |
| Mission Hospital, Inc. | Asheville | North Carolina | 28806 | — |
| UPMC Cancer Center, Monroeville | Monroeville | Pennsylvania | 15146 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| The Jones Clinic, PC | Germantown | Tennessee | 38138 | — |
| Texas Oncology- Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| Investigational Products Center (IPC) | Fort Worth | Texas | 76177 | — |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | — |
| US Oncology lnvestigational Products Center (IPC) | Irving | Texas | 75063 | — |
| Texas Oncology- Longview Cancer Center | Longview | Texas | 75601 | — |
| Texas Oncology- McAllen South Second Street | McAllen | Texas | 78503 | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78212 | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78217 | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78258 | — |
| Texas Oncology- Tyler | Tyler | Texas | 75702 | — |
| Texas Oncology- Weslaco | Weslaco | Texas | 78596 | — |
| Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Virginia Cancer Specialists, PC | Arlington | Virginia | 22205 | — |
| Emily Couric Clinical Cancer Center | Charlottesville | Virginia | 22903 | — |
| Inova Medical Group | Fairfax | Virginia | 22031 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Specialists, PC | Leesburg | Virginia | 20176 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Virginia Oncology Associates | Virginia Beach | Virginia | 23456 | — |
| Shenandoah Oncology, P.C. | Winchester | Virginia | 22601 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Swedish Medical Center First Hill IDS Pharmacy | Seattle | Washington | 98104 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| Columbia St. Mary's | Mequon | Wisconsin | 53097 | — |
| Columbia St. Mary's | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 113 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01942135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2024 · Synced Oct 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01942135 live on ClinicalTrials.gov.