Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT01942135
- Lead Sponsor
- Pfizer
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 521
- Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
- Confirmed diagnosis of HR+/HER2- breast cancer
- Any menopausal status
- Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
- On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
- Measurable disease defined by RECIST version 1.1, or bone-only disease
- Eastern Cooperative Oncology Group (ECOG) PS 0-1
- Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
- Patient must agree to provide tumor tissue from metastatic tissue at baseline
- Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway
- Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
- Major surgery or any anti-cancer therapy within 2 weeks of randomization
- Prior stem cell or bone marrow transplantation
- Use of potent CYP3A4 inhibitors or inducers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Palbociclib Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. Arm B Placebo Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. Arm A Fulvestrant Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. Arm B Fulvestrant Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) as Assessed by the Investigator From randomization date to date of first documentation of progression or death (assessed up to 12 months) PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were censored at the time of last objective assessment that did not show PD. The length of PFS was calculated as PFS time (months) =\[progression/death date(censor date) - randomization date + 1\]/30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors(RECIST v1.1) a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of existing non-target lesions or the appearance of new lesions.
- Secondary Outcome Measures
Name Time Method Ctrough for Goserelin Cycles 2/ Day 1 and Cycle 3/ Day 1 Ctrough was defined as steady-state predose concentration. Observed directly from data. For goserelin, a steady-state trough was to be defined when a patient had received all prior planned doses and the sample was collected predose.
Overall Survival (OS)-Number of Participants Who Died From randomization until death (up to 4.5 years) OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization were to have their OS times be censored at randomization. The length of OS was calculated as OS time (months) = \[death date (censor date) - randomization date + 1\]/30.4.
Overall Survival (OS) From randomization until death (up to 4.5 years) OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization were to have their OS times be censored at randomization. The length of OS was calculated as OS time (months) = \[death date (censor date) - randomization date + 1\]/30.4.
Survival Probabilities at Year 1, Year 2, and Year 3 From randomization until death (assessed up to 36 months) One-, Two- or Three-year Survival Probability is defined as the probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate. Survival time was censored to last date the participant is known to be alive.
Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores From Cycle 1 to 14, as of 05 December 2014. The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.
Objective Response (OR) From randomization until end of treatment (assessed up to 2 years) OR is defined as the overall complete response (CR) or partial response (PR) according to the RECIST version 1.1 Objective Response Rate (ORR) is defined as the proportion of participants with CR or PR relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per response evaluation criteria in solid tumors criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions (longest for non-nodal and short axis for nodal target lesions); Overall Response (OR) = CR + PR.
Duration of Response (DR) From randomization until end of treatment (assessed up to 2 years) DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \[the date response ended (ie, date of PD or death) - first CR or PR date + 1)\]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or PR.
Clinical Benefit Response (CBR) From randomization until end of treatment (assessed up to 2 years) CBR is defined as the overall complete response (CR), partial response (PR) , or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Clinical Benefit Response Rate (CBRR) is defined as the proportion of participants with CR, PR, or SD ≥24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received antitumor treatment other than the study medication prior to reaching a CR or PR, a best response of SD ≥24 weeks, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR and a best response of SD ≥24 weeks was counted as non-responders in the assessment of CBR. Per RECIST v1.1 for target lesions and assessed by MRI: CR, disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
Observed Plasma Trough Concentration (Ctrough) for Palbociclib Cycle 1/Day 15 and Cycle 2/Day 15 Ctrough was defined as steady-state predose concentration. Observed directly from data. For palbociclib, a steady-state trough was to be defined as a predose plasma concentration following at least 8 consecutive days of 125 mg daily dose without dosing interruption and the time window for the PK collection was to be between 22 and 26 hours after the dose (the day prior to PK collection) and no more than 1 hour post-dose on the day of PK collection.
Ctrough for Fulvestrant Cycles 2/Day 1 and Cycle 3/Day 1 Ctrough was defined as steady-state predose concentration. Observed directly from data. For fulvestrant, a steady-state trough was to be defined when a patient had received all prior planned doses and the sample was collected predose.
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores From Cycle 1 to 14, as of 05 December 2014. The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.
Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores From Cycle 1 to 14, as of 05 December 2014. The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores From Cycle 1 to 14, as of 05 December 2014. The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.
Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores From Cycle 1 to 14, as of 05 December 2014. The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/ impairment Published weights are available that allow for the creation of a single summary score called the EQ-5D index, which basically ranges from 0 to 1 with low scores representing a higher level of dysfunction and 1 as perfect health. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale From Cycle 1 to 14, as of 05 December 2014. The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time to Deterioration (TTD) Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment, as of 05 December 2014 A time to event analysis was pre-specified for pain. An analysis of TTD in pain defined as time between baseline and first occurrence of increase of ≥10 points in pain. Deterioration will be defined increase in score of 10 points or greater from baseline. The Kaplan-Meier estimates of quartiles (time to deterioration) with 95% CI is mentioned below.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities) From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years). An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.
Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Hematology Results From baseline to end of treatment/withdrawal (up to 4.5 years) Number of participants with shifts from Grade ≤2 at baseline values to post-baseline values (shift to Grade 3 or 4) were reported as per NCI-CTCAE, V4.0 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Shifts in lab parameter from Grade ≤2 at baseline to Grade 3 or 4 postbaseline (for parameters Anemia, Hemoglobin increased, Neutrophil count decreased, Platelet count decreased, and White blood cell count decreased) were reported.
Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Chemistry Results From baseline to end of treatment/withdrawal (up to 4.5 years) Number of participants with shifts from Grade ≤2 at baseline values to post-baseline values (shift to Grade 3 or 4) were reported as per NCI-CTCAE, V4.0 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Shifts in lab parameter from Grade ≤2 at baseline to Grade 3 or 4 postbaseline (for parameters ALT increased, ALP increased, AST increased, Blood bilirubin increased, Creatinine increased, Hypercalcemia, Hyperkalemia, Hypermagnesemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypokalemia, Hypomagnesemia, and Hyponatremia) were reported.
Trial Locations
- Locations (217)
Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center
🇺🇸Fort Lauderdale, Florida, United States
Sylvester Comprehensive Cancer Center Deerfield Beach
🇺🇸Deerfield Beach, Florida, United States
Memorial Cancer Institute at Memorial Hospital West
🇺🇸Pembroke Pines, Florida, United States
Memorial Hospital West
🇺🇸Pembroke Pines, Florida, United States
Inova Medical Group
🇺🇸Fairfax, Virginia, United States
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Swedish Medical Center First Hill IDS Pharmacy
🇺🇸Seattle, Washington, United States
University of Miami Hospitals & Clinics
🇺🇸Miami, Florida, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Clinique Saint-Pierre
🇧🇪Ottignies, Brabant Wallon, Belgium
Institut Jules Bordet
🇧🇪Bruxelles, Bruxelles Capitale, Belgium
Ikazia Ziekenhuis
🇳🇱Rotterdam, Zuid-holland, Netherlands
CHWaPi - Site IMC
🇧🇪Tournai, Hainaut, Belgium
KNP Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi
🇺🇦Lviv, Ukraine
The Royal Marsden NHS Foundation Trust
🇬🇧Sutton, United Kingdom
Velindre Cancer Centre
🇬🇧Cardiff, South Glamorgan, United Kingdom
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Royal Hallamshire Hospital
🇬🇧Sheffield, South Yorkshire, United Kingdom
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Komunalne nekomertsiyne pidpryiemstvo "Oblasnyi
🇺🇦Kharkiv, Ukraine
Komunalna ustanova "Odeska oblasna klinichna likarnia"
🇺🇦Odesa, Ukraine
Ege University Medical Faculty
🇹🇷Izmir, Bornova, Turkey
Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust Portsmouth Haematology and Oncology Centre
🇬🇧Portsmouth, Hampshire, United Kingdom
Saint Petersburg GBUZ "City Clinical Oncology Dispensary"
🇷🇺Saint Petersburg, Russian Federation
Komunalnyi zaklad 'Miska klinichna likarnia No.4' Dniprovskoi miskoi rady,
🇺🇦Dnipro, Ukraine
University of Minnesota Medical Center, Fairview
🇺🇸Minneapolis, Minnesota, United States
Fiona Stanley Hospital - Cancer Centre
🇦🇺Murdoch, Western Australia, Australia
Swedish Medical Center
🇺🇸Seattle, Washington, United States
British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
INDC Entité Jolimontoise - CH de Jolimont-Lobbes
🇧🇪Haine St. Paul, Hainaut, Belgium
Bon Secours Hospital
🇮🇪Cork, Ireland
Spitalul Clinic CF nr.2 Bucuresti
🇷🇴Bucharest, Romania
Spitalul Judetean de Urgente "Sf. Ioan cel Nou"
🇷🇴Suceava, Romania
Grand Hôpital de Charleroi - Site Notre Dame
🇧🇪Charleroi, Hainaut, Belgium
Orbis Medisch Centrum
🇳🇱Sittard-Geleen, Limburg, Netherlands
Spitalul Municipal Ploiesti
🇷🇴Ploiesti, Romania
Instituto Português de Oncologia
🇵🇹Porto, Portugal
Spitalul Clinic Judetean Mures
🇷🇴Tg. Mures, Romania
University of Alabama at Birmingham, The Kirklin Clinic
🇺🇸Birmingham, Alabama, United States
UAB Hospital-Investigational Drug Service
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, San Francisco: Helen Diller Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Huntsman Cancer Hospital
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
National Hospital Organization
🇯🇵Osaka, Japan
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
GBUZ Leningrad regional oncological dispensary
🇷🇺Village Kuzmolovsky, Leningradskaya Oblast', Russian Federation
GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary"
🇷🇺Pyatigorsk,, Stavropol Territory, Russian Federation
FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency"
🇷🇺Lermontov, Stavropol Territory, Russian Federation
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
UCLA Hematology/Oncology - Pasadena
🇺🇸Pasadena, California, United States
UCLA Hematology/Oncology - Santa Monica
🇺🇸Santa Monica, California, United States
Southern Cancer Center,PC
🇺🇸Mobile, Alabama, United States
Southern Cancer Center, PC
🇺🇸Mobile, Alabama, United States
Arizona Center for Cancer Care
🇺🇸Surprise, Arizona, United States
Arizona Oncology Associates, PC- HAL
🇺🇸Sedona, Arizona, United States
Palo Verde Hematology Oncology
🇺🇸Glendale, Arizona, United States
Western Regional Medical Center, Inc.
🇺🇸Goodyear, Arizona, United States
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
🇺🇸Mesa, Arizona, United States
Administrative Management Only: Translational Research Management
🇺🇸Culver City, California, United States
The University of Arizona Cancer Center- North Campus
🇺🇸Tucson, Arizona, United States
CBCC Global Research Inc. at Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
City of Hope
🇺🇸South Pasadena, California, United States
Global Research Management
🇺🇸Glendale, California, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
UC San Diego Medical Center-La Jolla
🇺🇸La Jolla, California, United States
LAC & USC Medical Center
🇺🇸Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
UCLA Hematology Oncology
🇺🇸Los Angeles, California, United States
UC San Diego Medical Center-Hillcrest
🇺🇸San Diego, California, United States
Hematology Oncology Medical Group of Orange County, Inc. (HOMG)
🇺🇸Orange, California, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
🇺🇸Orange, California, United States
Breastlink Medical Group, Inc.
🇺🇸Santa Ana, California, United States
San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers
🇺🇸San Luis Obispo, California, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
UCLA Hematology - Oncology Clinic - Westlake Village
🇺🇸Westlake Village, California, United States
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates
🇺🇸Torrance, California, United States
Torrance Memorial Physician Network-Cancer Care
🇺🇸Torrance, California, United States
Wellness Oncology & Hematology
🇺🇸West Hills, California, United States
Mount Sinai Medical Center- Aventura
🇺🇸Aventura, Florida, United States
University of Miami Hospitals and Clinics (UHMC) Sylvester at Deerfield Beach
🇺🇸Deerfield Beach, Florida, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Memorial Breast Cancer Center at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Orlando Health
🇺🇸Ocoee, Florida, United States
Memorial Breast Cancer Center at Memorial Hospital West
🇺🇸Pembroke Pines, Florida, United States
Sylvester at Plantation
🇺🇸Plantation, Florida, United States
Piedmont Cancer Institute, PC
🇺🇸Fayetteville, Georgia, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
🇺🇸Marietta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
🇺🇸Austell, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Northwest Georgia Oncology Centers, PC
🇺🇸Marietta, Georgia, United States
Cancer Treatment Centers of America at Midwestern Regional Medical Center
🇺🇸Zion, Illinois, United States
Maine Center for Cancer Medicine, dba: New England Cancer Specialists
🇺🇸Scarborough, Maine, United States
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station
🇺🇸Lutherville, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Cancer and Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Fairview Southdale Oncology Clinic
🇺🇸Edina, Minnesota, United States
Mercy Ministry Office
🇺🇸Chesterfield, Missouri, United States
Mercy Clinic St. Louis Cancer and Breast Institute
🇺🇸Saint Louis, Missouri, United States
University of Minnesota Physicians, Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Mercy Hospital St.Louis- David C. Pratt Cancer Center
🇺🇸Saint Louis, Missouri, United States
Hope Women's Cancer Centers
🇺🇸Asheville, North Carolina, United States
ProHEALTHCARE Associates, LLP
🇺🇸Lake Success, New York, United States
Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
CareMount Medical
🇺🇸Mount Kisco, New York, United States
Mission Hospital, Inc.
🇺🇸Asheville, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Cancer Center, Monroeville
🇺🇸Monroeville, Pennsylvania, United States
Magee Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Oncology- Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
The Jones Clinic, PC
🇺🇸Germantown, Tennessee, United States
Investigational Products Center (IPC)
🇺🇸Fort Worth, Texas, United States
US Oncology lnvestigational Products Center (IPC)
🇺🇸Irving, Texas, United States
US Oncology Investigational Products Center (IPC)
🇺🇸Irving, Texas, United States
Texas Oncology- Longview Cancer Center
🇺🇸Longview, Texas, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Texas Oncology- McAllen South Second Street
🇺🇸McAllen, Texas, United States
Texas Oncology- Weslaco
🇺🇸Weslaco, Texas, United States
Texas Oncology- Tyler
🇺🇸Tyler, Texas, United States
Emily Couric Clinical Cancer Center
🇺🇸Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
🇺🇸Leesburg, Virginia, United States
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
Virginia Oncology Associates
🇺🇸Virginia Beach, Virginia, United States
Shenandoah Oncology, P.C.
🇺🇸Winchester, Virginia, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Bankstown - Lidcombe Hospital
🇦🇺Bankstown, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
River City Pharmacy
🇦🇺Auchenflower, Queensland, Australia
Icon Cancer Care Southport
🇦🇺Southport, Queensland, Australia
Sunshine Coast Hospital and Health Service
🇦🇺Nambour, Queensland, Australia
Cabrini Brighton
🇦🇺Brighton, Victoria, Australia
Peter MacCallum Cancer Centre Pharmacy
🇦🇺Melbourne, Victoria, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Peninsula and Southeast Oncology
🇦🇺Frankston, Victoria, Australia
Barwon Health, University Hospital Geelong
🇦🇺Geelong, Victoria, Australia
Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
UZ Antwerpen
🇧🇪Edegem, Antwerpen, Belgium
Sunshine Hospital Clinical Trials Pharmacy
🇦🇺St Albans, Victoria, Australia
C.H. de l'Ardenne - site Libramont
🇧🇪Libramont-Chevigny, Luxembourg, Belgium
Royal Victoria Regional Health Centre
🇨🇦Barrie, Ontario, Canada
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Cancer Centre of Southeastern Ontario @ Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre
🇨🇦Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre, General Campus
🇨🇦Ottawa, Ontario, Canada
Niagara Health System Walker Family Cancer Center
🇨🇦St. Catharines, Ontario, Canada
Sunnybrook Research Institute
🇨🇦Toronto, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Universitaetsklinikum Leipzig AoeR
🇩🇪Leipzig, Germany
Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz
🇩🇪Leipzig, Germany
U.O. di Oncologia Medica P.O. Policlinico G. Rodolico"
🇮🇹Catania, Italy
Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata Farmacia Interna
🇮🇹Bagno A Ripoli (FI), Italy
Farmacia Ospedaliera-Azienda U.L.S.S. n. 21 di Legnago
🇮🇹Legnago (VR), Italy
S.O.C. Oncologia Medica I, Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata
🇮🇹Bagno A Ripoli (FI), Italy
SSD Oncologia Medica Addarii-Zamagni A.O.U. di Bologna Policlinico S. Orsola Malpighi
🇮🇹Bologna, Italy
Klinikum der Universität München
🇩🇪München, Germany
Azienda U.L.S.S. n. 21 di Legnago, Presidio Ospedaliero Mater Salutis
🇮🇹Legnago (VR), Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
IRCCS Ospedale S. Raffaele
🇮🇹Milano, Italy
IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola (FC), Italy
Farmacia IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Policlinico di Modena Dipartimento ad attivita integrata di Oncologia,
🇮🇹Modena, Italy
Servizio di Farmacia - Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Fondazione Policlinico Universitario A. Gemelli
🇮🇹Roma, Italy
IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Napoli, Italy
S.C. Oncologia, A.O.S. Maria
🇮🇹Terni, Italy
Farmacia - Fondazione Policlinico Universitario A. Gemelli
🇮🇹Roma, Italy
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama-city, Ehime, Japan
Saitama Cancer Center
🇯🇵Kita-adachi-gun, Saitama,japan, Japan
Hakuaikai Medical Corporation Sagara Hospital
🇯🇵Kagoshima, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Limburg, Netherlands
TweeSteden Ziekenhuis
🇳🇱Tilburg, Noord-brabant, Netherlands
Asan medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Haga Ziekenhuis
🇳🇱Den Haag, Zuid-holland, Netherlands
Leids Universitair Medisch Centrum
🇳🇱Leiden, Zuid-holland, Netherlands
Champalimaud Cancer Center/ Breast Unit
🇵🇹Lisboa, Portugal
OGBUZ Belgorod Oncology Dispensary
🇷🇺Stariy Oskol, Belgorodskaya Oblast', Russian Federation
GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan
🇷🇺Ufa, Republic OF Bashkortostan, Russian Federation
GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine
🇷🇺Chelyabinsk, Russian Federation
FSBSI Russian Cancer Research Center n.a.NN Blokhin
🇷🇺Moscow, Russian Federation
Saint Petersburg GBUZ City Clinical Oncology Dispensary
🇷🇺Saint Petersburg, Russian Federation
GBUZ of Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
🇷🇺Stavropol, Russian Federation
FGBU Russian Research Center for Radiology and Surgical Technologies
🇷🇺Village Pesochny, Russian Federation
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr"
🇺🇦Chernivtsi, Ukraine
Podilskyi rehionalnyi tsentr onkolohii,
🇺🇦Vinnytsia, Ukraine
Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital
🇬🇧Sheffield, South Yorkshire, United Kingdom
ATTN - Research Pharmacist
🇺🇸Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
🇺🇸Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
🇺🇸Aurora, Colorado, United States
Orlando Health Cancer Institute
🇺🇸Orlando, Florida, United States
University of Michigan Health System/Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Columbia St. Mary's
🇺🇸Milwaukee, Wisconsin, United States
Hopital Erasme
🇧🇪Bruxelles, Region DE Bruxelles-capital, Belgium
UZ Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
CHU UCL Namur - Site Sainte-Elisabeth
🇧🇪Namur, Belgium
GZA Ziekenhuizen - Campus St Augustinus
🇧🇪Wilrijk, Belgium
The University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
British Columbia Cancer Agency - Fraser Valley Centre
🇨🇦Surrey, British Columbia, Canada
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
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