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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01942135
Registration number
NCT01942135
Ethics application status
Date submitted
10/09/2013
Date registered
13/09/2013
Date last updated
4/04/2024
Titles & IDs
Public title
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
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Scientific 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
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Secondary ID [1]
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2013-002580-26
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Secondary ID [2]
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A5481023
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Palbociclib
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Placebo
Treatment: Drugs - Fulvestrant
Experimental: Arm A - Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Active Comparator: Arm B - Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Treatment: Drugs: Palbociclib
Palbociclib 125 mg/day orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
Treatment: Drugs: Fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
Treatment: Drugs: Placebo
Placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
Treatment: Drugs: Fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) as Assessed by the Investigator
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization date to date of first documentation of progression or death (assessed up to 12 months)
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Secondary outcome [1]
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Overall Survival (OS)-Number of Participants Who Died
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization until death (up to 4.5 years)
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization until death (up to 4.5 years)
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Secondary outcome [3]
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Survival Probabilities at Year 1, Year 2, and Year 3
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Assessment method [3]
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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.
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Timepoint [3]
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From randomization until death (assessed up to 36 months)
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Secondary outcome [4]
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Objective Response (OR)
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Assessment method [4]
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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.
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Timepoint [4]
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From randomization until end of treatment (assessed up to 2 years)
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Secondary outcome [5]
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Duration of Response (DR)
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Assessment method [5]
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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.
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Timepoint [5]
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From randomization until end of treatment (assessed up to 2 years)
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Secondary outcome [6]
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Clinical Benefit Response (CBR)
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Assessment method [6]
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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.
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Timepoint [6]
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From randomization until end of treatment (assessed up to 2 years)
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Secondary outcome [7]
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Observed Plasma Trough Concentration (Ctrough) for Palbociclib
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Assessment method [7]
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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.
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Timepoint [7]
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Cycle 1/Day 15 and Cycle 2/Day 15
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Secondary outcome [8]
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Ctrough for Fulvestrant
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Assessment method [8]
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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.
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Timepoint [8]
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Cycles 2/Day 1 and Cycle 3/Day 1
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Secondary outcome [9]
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Ctrough for Goserelin
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Assessment method [9]
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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.
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Timepoint [9]
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Cycles 2/ Day 1 and Cycle 3/ Day 1
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Secondary outcome [10]
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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
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Assessment method [10]
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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.
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Timepoint [10]
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From Cycle 1 to 14, as of 05 December 2014.
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Secondary outcome [11]
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Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores
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Assessment method [11]
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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.
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Timepoint [11]
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From Cycle 1 to 14, as of 05 December 2014.
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Secondary outcome [12]
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Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
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Assessment method [12]
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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.
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Timepoint [12]
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From Cycle 1 to 14, as of 05 December 2014.
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Secondary outcome [13]
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Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores
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Assessment method [13]
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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.
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Timepoint [13]
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From Cycle 1 to 14, as of 05 December 2014.
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Secondary outcome [14]
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Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores
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Assessment method [14]
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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).
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Timepoint [14]
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From Cycle 1 to 14, as of 05 December 2014.
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Secondary outcome [15]
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Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale
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Assessment method [15]
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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).
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Timepoint [15]
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From Cycle 1 to 14, as of 05 December 2014.
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Secondary outcome [16]
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Time to Deterioration (TTD)
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Assessment method [16]
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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.
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Timepoint [16]
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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
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Secondary outcome [17]
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)
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Assessment method [17]
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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.
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Timepoint [17]
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From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).
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Secondary outcome [18]
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Participants With Shifts From CTCAE Grade =2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Hematology Results
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Assessment method [18]
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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.
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Timepoint [18]
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From baseline to end of treatment/withdrawal (up to 4.5 years)
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Secondary outcome [19]
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Participants With Shifts From CTCAE Grade =2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Chemistry Results
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Assessment method [19]
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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.
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Timepoint [19]
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From baseline to end of treatment/withdrawal (up to 4.5 years)
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Eligibility
Key inclusion criteria
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/09/2022
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Sample size
Target
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Accrual to date
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Final
521
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Bankstown - Lidcombe Hospital - Bankstown
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Recruitment hospital [2]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [3]
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0
River City Pharmacy - Auchenflower
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Recruitment hospital [4]
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0
Sunshine Coast Hospital and Health Service - Nambour
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Recruitment hospital [5]
0
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Icon Cancer Care Southport - Southport
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Recruitment hospital [6]
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Cabrini Brighton - Brighton
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Recruitment hospital [7]
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0
Monash Medical Centre - Clayton
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Recruitment hospital [8]
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Peninsula and Southeast Oncology - Frankston
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Recruitment hospital [9]
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Barwon Health, University Hospital Geelong - Geelong
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Recruitment hospital [10]
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Cabrini Hospital - Malvern
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Recruitment hospital [11]
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0
Peter MacCallum Cancer Centre Pharmacy - Melbourne
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Recruitment hospital [12]
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0
Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [13]
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0
Sunshine Hospital Clinical Trials Pharmacy - St Albans
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Recruitment hospital [14]
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0
Sunshine Hospital - St Albans
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Recruitment hospital [15]
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0
Fiona Stanley Hospital - Cancer Centre - Murdoch
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Recruitment postcode(s) [1]
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0
2200 - Bankstown
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Recruitment postcode(s) [2]
0
0
2298 - Waratah
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Recruitment postcode(s) [3]
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4066 - Auchenflower
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Recruitment postcode(s) [4]
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0
4560 - Nambour
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Recruitment postcode(s) [5]
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0
4215 - Southport
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Recruitment postcode(s) [6]
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0
3186 - Brighton
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Recruitment postcode(s) [7]
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0
3168 - Clayton
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Recruitment postcode(s) [8]
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0
3199 - Frankston
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Recruitment postcode(s) [9]
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0
3220 - Geelong
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Recruitment postcode(s) [10]
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0
3144 - Malvern
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Recruitment postcode(s) [11]
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0
3000 - Melbourne
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Recruitment postcode(s) [12]
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0
3021 - St Albans
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Recruitment postcode(s) [13]
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0
6150 - Murdoch
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
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0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Maine
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Maryland
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Michigan
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Minnesota
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Country [12]
0
0
United States of America
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State/province [12]
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0
Missouri
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Country [13]
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0
United States of America
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State/province [13]
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Nevada
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Country [14]
0
0
United States of America
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State/province [14]
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0
New Jersey
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Country [15]
0
0
United States of America
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State/province [15]
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0
New York
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Country [16]
0
0
United States of America
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State/province [16]
0
0
North Carolina
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Country [17]
0
0
United States of America
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State/province [17]
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0
Pennsylvania
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Country [18]
0
0
United States of America
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State/province [18]
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0
Tennessee
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Texas
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Utah
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Country [21]
0
0
United States of America
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State/province [21]
0
0
Virginia
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Country [22]
0
0
United States of America
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State/province [22]
0
0
Washington
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Country [23]
0
0
United States of America
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State/province [23]
0
0
Wisconsin
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Country [24]
0
0
Belgium
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State/province [24]
0
0
Antwerpen
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Country [25]
0
0
Belgium
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State/province [25]
0
0
Brabant Wallon
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0
0
Belgium
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0
0
Bruxelles Capitale
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Country [27]
0
0
Belgium
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0
Hainaut
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Country [28]
0
0
Belgium
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0
Luxembourg
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Country [29]
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Belgium
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Region DE Bruxelles-capital
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Belgium
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0
Bonheiden
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Country [31]
0
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Namur
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Belgium
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Wilrijk
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Canada
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Canada
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Ontario
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Canada
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Quebec
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Germany
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Leipzig
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Germany
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München
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Ireland
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Cork
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Italy
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Italy
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Italy
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Catania
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Italy
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Italy
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Meldola (FC)
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Roma
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Italy
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Terni
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Saitama,japan
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Japan
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Fukuoka
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0
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Japan
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Kagoshima
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Japan
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Osaka
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Netherlands
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Limburg
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Netherlands
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Netherlands
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Zuid-holland
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Country [63]
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Portugal
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Lisboa
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Portugal
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Porto
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Country [65]
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Romania
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Bucharest
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Country [66]
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Romania
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Ploiesti
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Country [67]
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Romania
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Suceava
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Country [68]
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Romania
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Tg. Mures
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Country [69]
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Russian Federation
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State/province [69]
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Belgorodskaya Oblast',
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Country [70]
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Russian Federation
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Belgorodskaya Oblast'
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Country [71]
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Russian Federation
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Leningradskaya Oblast'
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Country [72]
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Russian Federation
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State/province [72]
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Republic OF Bashkortostan
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Country [73]
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Russian Federation
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Stavropol Territory
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Country [74]
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Russian Federation
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Chelyabinsk
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Country [75]
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Russian Federation
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Moscow
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Country [76]
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Russian Federation
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Saint Petersburg
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Country [77]
0
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Russian Federation
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Stavropol
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Country [78]
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Russian Federation
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Village Pesochny
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Country [79]
0
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Taiwan
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Tainan
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Country [80]
0
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Taiwan
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Taipei
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Country [81]
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Turkey
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Bornova
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Country [82]
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Ukraine
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Chernivtsi
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Country [83]
0
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Ukraine
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Dnipro
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Country [84]
0
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Ukraine
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0
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Kharkiv
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Country [85]
0
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Ukraine
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Lviv
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Country [86]
0
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Ukraine
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State/province [86]
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Odesa
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Country [87]
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Ukraine
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Vinnytsia
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Country [88]
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United Kingdom
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State/province [88]
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Hampshire
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Country [89]
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United Kingdom
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State/province [89]
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South Glamorgan
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Country [90]
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United Kingdom
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South Yorkshire
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Country [91]
0
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United Kingdom
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London
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Other collaborator category [1]
0
0
Commercial sector/Industry
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AstraZeneca
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01942135
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01942135
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