ClinicalTrials.gov record
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
ClinicalTrials.gov ID: NCT01740427
Public ClinicalTrials.gov record NCT01740427. 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
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
Study identification
- NCT ID
- NCT01740427
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 666 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
- Feb 22, 2013 (Actual)
- Primary completion
- Feb 26, 2016 (Actual)
- Completion
- Nov 9, 2023 (Actual)
- Last update posted
- Nov 14, 2024
2013 – 2023
United States locations
- U.S. sites
- 136
- U.S. states
- 24
- U.S. cities
- 86
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Permanente Medical Group | Bellflower | California | 90706 | — |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | — |
| St. Joseph Heritage Healthcare | Fullerton | California | 92835 | — |
| Los Angeles Hematology/Oncology Medical Group | Glendale | California | 91206 | — |
| UCLA Hematology/ Oncology- Irvine | Irvine | California | 92604 | — |
| UCLA Hematology Oncology- Laguna Hills | Laguna Hills | California | 92653 | — |
| Los Angeles Hematology/Oncology Medical Group | Los Angeles | California | 90017 | — |
| Southern California Permanente Medical Group | Los Angeles | California | 90027 | — |
| Translational Research Management | Los Angeles | California | 90045 | — |
| Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D. | Los Angeles | California | 90095-1772 | — |
| UCLA West Medical Pharmacy, Attn: Steven L. Wong | Los Angeles | California | 90095-7349 | — |
| UCLA West Medical Pharmacy: Drug Management Only | Los Angeles | California | 90095-7349 | — |
| UCLA West Medical Pharmacy; Drug Management Only | Los Angeles | California | 90095-7349 | — |
| UCLA West Medical Pharmacy | Los Angeles | California | 90095-7349 | — |
| Administrative Address: UCLA Hematology/Oncology | Los Angeles | California | 90095 | — |
| Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D. | Los Angeles | California | 90095 | — |
| Regulatory Management Only: TRIO-US Central Administration | Los Angeles | California | 90095 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | — |
| TRIO-US Central Administration: Regulatory Management Only | Los Angeles | California | 90095 | — |
| TRIO-US Central Administration | Los Angeles | California | 90095 | — |
| UCLA Hematology Oncology | Los Angeles | California | 90095 | — |
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | — |
| UCLA Hematology/ Oncology- Pasadena | Pasadena | California | 91105 | — |
| Torrance Health Association, DBa Torrance Memorial Physician Network | Redondo Beach | California | 90277 | — |
| Southern California Permanente Medical Group | San Diego | California | 92108 | — |
| University of California, San Francisco | San Francisco | California | 94115 | — |
| University of California San Francisco - Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | — |
| San Luis Obispo Oncology and Hematology Health Center/ Pacific Central Coast Health Centers | San Luis Obispo | California | 93401 | — |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | — |
| UCLA Santa Monica Medical Center and Orthopaedic Hospital | Santa Monica | California | 90404 | — |
| Stanford Women's Cancer Center | Stanford | California | 94304-5826 | — |
| Wellness Oncology & Hematology | West Hills | California | 91307 | — |
| UCLA Hematology/Oncology- Westlake | Westlake Village | California | 91361 | — |
| St. Mary's Hospital Regional Cancer Center | Grand Junction | Colorado | 81501 | — |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | — |
| Whittingham Cancer Center @ Norwalk Hospital | Norwalk | Connecticut | 06856 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Sylvester at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| 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 | — |
| Cancer Specialist of North Florida, Pharmacy | Jacksonville | Florida | 32256 | — |
| Cancer Specialists of North Florida-Southpoint | Jacksonville | Florida | 32256 | — |
| Orlando Health, Inc. | 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 Comprehensive Cancer Center Plantation | Plantation | Florida | 33324 | — |
| Cancer Specialists of North Florida - St. Augustine | Saint Augustine | Florida | 32086 | — |
| Grady Health System | Atlanta | Georgia | 30303 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Northwest Georgia Oncology Centers, PC | Marietta | Georgia | 30060 | — |
| Kootenai Clinic Cancer Services | Coeur d'Alene | Idaho | 83814 | — |
| Kootenai Clinic Cancer Services | Post Falls | Idaho | 83854 | — |
| The Mark M. Connolly Center for Cancer and Specialty Care | Chicago | Illinois | 60657 | — |
| Carle Foundation Hospital DBA Carle Cancer Center | Danville | Illinois | 61832 | — |
| Carle Foundation Hospital DBA Carle Cancer Center | Effingham | Illinois | 62401 | — |
| Presence Infusion Care- Evanston | Evanston | Illinois | 60202 | — |
| Carle Foundation Hospital DBA Carle Cancer Center | Mattoon | Illinois | 61938 | — |
| Presence Infusion Care- Skokie | Skokie | Illinois | 60077 | — |
| Carle Foundation Hospital DBA Carle Cancer Center | Urbana | Illinois | 61801 | — |
| James Graham Brown Cancer Center and University Hospital | Louisville | Kentucky | 40202 | — |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| University of Maryland, Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Park Nicollet Frauenshuh Cancer Center | Saint Louis Park | Minnesota | 55426 | — |
| The West Clinic, PC | Corinth | Mississippi | 38834 | — |
| The West Clinic, PC dba West Cancer Centre | Southaven | Mississippi | 38671 | — |
| Mercy Clinic St. Louis Cancer and Breast Institute | Ballwin | Missouri | 63011 | — |
| Mercy Clinic St. Louis Cancer and Breast Institute | St Louis | Missouri | 63109 | — |
| Mercy Hospital St. Louis - David C. Pratt Cancer Center | St Louis | Missouri | 63141 | — |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | — |
| Saint Francis Medical Center | Grand Island | Nebraska | 68802 | — |
| Saint Francis Medical Center, Saint Francis Cancer Treatment Center | Grand Island | Nebraska | 68803 | — |
| Saint Francis Medical Center | Hastings | Nebraska | 68901 | — |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052 | — |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074-8195 | — |
| Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department | Las Vegas | Nevada | 89119 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| CareMount Medical | Brewster | New York | 10509 | — |
| CareMount Medical | Mount Kisco | New York | 10549 | — |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Stony Brook University- Cancer Center | Stony Brook | New York | 11794-9447 | — |
| Northwest Cancer Specialists, PC | Portland | Oregon | 97213 | — |
| Kaiser Permanente Northwest Region | Portland | Oregon | 97227 | — |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | — |
| OHSU Center for Health and Healing 2 | Portland | Oregon | 97239 | — |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | — |
| OHSU Research Pharmacy Services | Portland | Oregon | 97239 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Tennessee Oncology, PLLC | Dickson | Tennessee | 37055 | — |
| Tennessee Oncology PLLC | Franklin | Tennessee | 37067 | — |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | — |
| The West Clinic, PC dba West Cancer Centre | Germantown | Tennessee | 38138 | — |
| Tennessee Oncology PLLC | Hermitage | Tennessee | 37076 | — |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37090 | — |
| The West Clinic, PC dba West Cancer Centre | Memphis | Tennessee | 38104 | — |
| Tennessee Oncology PLLC | Murfreesboro | Tennessee | 37129 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37205 | — |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37207 | — |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37211 | — |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | — |
| Tennessee Oncology PLLC | Smyrna | Tennessee | 37167 | — |
| Texas Oncology-Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas oncology-west Texas | El Paso | Texas | 79902 | — |
| Texas oncology-West Texas | El Paso | Texas | 79915 | — |
| Texas Oncology-west Texas | El Paso | Texas | 79938 | — |
| Investigational Products Center (IPC) | Fort Worth | Texas | 76177 | — |
| The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology | Houston | Texas | 77030 | — |
| The University of Texas MD Anderson Cancer Center. | Houston | Texas | 77030 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| US Oncology Investigational Products Center | Irving | Texas | 75063 | — |
| Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care | Blacksburg | Virginia | 24060 | — |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Low Moor | Virginia | 24457 | — |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | — |
| Virginia oncology Associates | Norfolk | Virginia | 23502 | — |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | — |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Salem | Virginia | 24153 | — |
| Virginia Oncology Associates | Virginia Beach | Virginia | 23456 | — |
| Shenandoah Oncology PC | Winchester | Virginia | 22601 | — |
| Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care | Wytheville | Virginia | 24382 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98683 | — |
| Northwest Cancer Specialists P.C. | Vancouver | Washington | 98684 | — |
| WVU Medicine | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin | Madison | Wisconsin | 53792-6164 | — |
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 169 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01740427, 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 Nov 14, 2024 · Synced Oct 23, 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 NCT01740427 live on ClinicalTrials.gov.