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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02297438
Other study ID # A5481027
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 23, 2015
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 340
Est. completion date December 31, 2024
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Adult Asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy - Confirmed diagnosis of ER positive breast cancer - No prior systemic anti-cancer therapy for advanced ER+ disease - Postmenopausal women - Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease - Eastern Cooperative Oncology Group [ECOG] 0-1 - Adequate organ and marrow function - Patient must agree to provide tumor tissue Exclusion Criteria: - Confirmed diagnosis of HER2 positive disease - Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term - Known uncontrolled or symptomatic CNS metastases - Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment - Prior treatment with any CDK 4/6 inhibitor

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Palbociclib
Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
Placebo
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Letrozole
Letrozole, 2.5mg, orally once daily (continuously)

Locations

Country Name City State
China 307 Hospital of PLA Beijing
China Beijing Cancer Hospital Beijing
China Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing
China Chinese PLA General Hospital/Oncology Beijing
China Peking University Third Hospital/Department of Oncology Beijing
China The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department Bengbu Anhui
China Jilin Provincial Cancer Hospital Changchun Jilin
China The First Hospital of Jilin University Changchun Jilin
China Hunan Provincial Tumor Hospital/Breast Internal Medicine Department Changsha Hunan
China The Second Xiangya Hospital of Central South University Changsha Hunan
China West China Hospital of Sichuan University Chengdu Sichuan
China Oncology Department, the Second Affiliated Hospital of Third Military Medical University, PLA Chongqing City
China Fujian Medical University Union Hospital/Medical Oncology Department Fuzhou Fujian
China Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Guangzhou Guangdong
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Sun Yat-Sen University Cancer Center Guangzhou Guangdong
China Zhongshan Ophthalmic Center,Sun Yat-Sen University Guangzhou Guangdong
China Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology Hangzhou Zhejiang
China The First Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou Zhejiang
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital/Oncology Department Harbin Heilongjiang
China The First Affiliated Hospital of Anhui Medical University Hefei Anhui
China The Tumor Hospital of Yunnan Province Kunming Yunnan
China Jiangsu Cancer Hospital Nanjing Jiangsu
China Jiangsu Province Hospital Nanjing Jiangsu
China Fudan University Shanghai Cancer Center Shanghai
China Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai
China Liaoning Province Cancer Hospital Shenyang Liaoning
China The First Hospital of China Medical University/Oncology Department Shenyang Liaoning
China Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
China Tianjin Cancer Hospital/Breast cancer department Tianjin Tianjin
China Hubei Cancer Hospital Wuhan Hubei
China Henan Cancer Hospital Zhengzhou Henan
Hong Kong Block R Hong Kong
Hong Kong Department of Clinical Oncology Hong Kong
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Queen Mary Hospital HongKong
Singapore Parkway Cancer Centre Singapore
Singapore Raffles Cancer Centre Singapore
Singapore Tan Tock Seng Hospital Singapore
Singapore Tan Tock Seng Hospital Singapore
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng Kung University Hospital / Internal Medicine Tainan
Taiwan Koo Foundation, Sun Yat-Sen Cancer Center Taipei
Taiwan Mackay Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Medical University Hospital/ Department of Surgery Taipei
Taiwan Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University ) Taipei
Taiwan Taipei Veterans General Hospital/Surgery Department Taipei
Thailand Division of Medical Oncology, Department of Medicine, Bangkok
Thailand Oncology Unit, Department of Internal Medicine, Phramongkutklao Hospital Bangkok
Thailand Ramathibodi Hospital, Mahidol University Bangkok Ratchathevi
Thailand Department of Medicine, Faculty of Medicine, Naresuan University Muang Phitsanulok
Thailand Division of Therapeutic Radiology and Oncology, Department of Radiology Muang Chiang MAI
Thailand King Chulalongkorn Memorial Hospital Pathumwan Bangkok
Thailand Chula Clinical Research Center (Chula CRC) Patumwan Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

China,  Hong Kong,  Singapore,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-Free Survival (PFS) Based on Investigator's Assessment PFS was based on Kaplan-Meier estimates. PFS was defined as 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 the absence of documented PD, whichever occurred first. PD is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. In this outcome measure, PFS was based on investigator's assessment. Randomization up to 65 months
Secondary Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) PFS was based on Kaplan-Meier estimates. PFS was defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause in the absence of documented progressive disease, whichever occurs first. In this outcome measure, PFS was based on BICR. Randomization up to 65 months
Secondary Percentage of Participants Wiht Objective Response (OR) Based on Investigator Assessment OR was defined as a complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 recorded from randomization until disease progression or death due to any cause. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. In this outcome measure, OR was based on investigator assessment. Randomization up to 65 months
Secondary Percentage of Participants With Objective Response (OR) Based on Investigator Assessment (Participants With Measureable Disease at Baseline) OR was defined as a complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 recorded from randomization until disease progression or death due to any cause. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. In this outcome measure, OR was based on investigator assessment. Randomization up to 65 months
Secondary Percentage of Participants With Objective Response (OR) Based on Blinded Independent Central Review (BICR) OR was defined as a complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 recorded from randomization until disease progression or death due to any cause. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. In this outcome measure, OR was based on BICR. Randomization up to 65 months
Secondary Percentage of Participants With Objective Response (OR) Based on Blinded Independent Central Review (BICR) (Participants With Measureable Disease at Baseline) OR was defined as a complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 recorded from randomization until disease progression or death due to any cause. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. In this outcome measure, OR was based on BICR. Randomization up to 65 months
Secondary Duration of Response (DOR) Based on Investigator Assessment (Participants With Objective Disease Response) DOR was defined as the time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. DOR data was censored on the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. In this outcome measure, DOR was based on investigator assessment. Randomization up to 65 months
Secondary Duration of Response (DOR) Based on Blinded Independent Central Review (BICR) (Participants With Objective Disease Response) DOR was defined as the time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. DOR data was censored on the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. In this outcome measure, DOR was based on BICR. Randomization up to 65 months
Secondary Percentage of Participants With Disease Control/Clinical Benefit Response (DC/CBR) Based on Investigator Assessment DC/CBR was defined as CR, PR, or stable disease (SD) >=24 weeks according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) recorded in the time period between randomization and disease progression or death to any cause. CR was defined as complete disappearance of all target lesions except for nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. SD was defined as not qualifying for CR, PR, PD. PD is defined using RECIST v1.1 as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. In this outcome measure, DC/CBR was based on investigator assessment. Randomization up to 65 months
Secondary Percentage of Participants With Disease Control/Clinical Benefit Response (DC/CBR) Based on Investigator Assessment (Participants With Measureable Disease at Baseline) DC/CBR was defined as CR, PR, or stable disease (SD) >=24 weeks according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) recorded in the time period between randomization and disease progression or death to any cause. CR was defined as complete disappearance of all target lesions except for nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. SD was defined as not qualifying for CR, PR, PD. PD is defined using RECIST v1.1 as a 20% increase in the sum of of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. In this outcome measure, DC/CBR was based on investigator assessment. Randomization up to 65 months
Secondary Percentage of Participants With Disease Control/Clinical Benefit Response (DC/CBR) Based on Blinded Independent Central Review (BICR) DC/CBR was defined as CR, PR, or stable disease (SD) >=24 weeks according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) recorded in the time period between randomization and disease progression or death to any cause. CR was defined as complete disappearance of all target lesions except for nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. SD was defined as not qualifying for CR, PR, PD. PD is defined using RECIST v1.1 as a 20% increase in the sum of of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. In this outcome measure, DC/CBR was based on BICR. Randomization up to 65 months
Secondary Percentage of Participants With Disease Control/Clinical Benefit Response (DC/CBR) Based on Blinded Independent Central Review (BICR) (Participants With Measureable Disease at Baseline) DC/CBR was defined as CR, PR, or stable disease (SD) >=24 weeks according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) recorded in the time period between randomization and disease progression or death to any cause. CR was defined as complete disappearance of all target lesions except for nodal disease. All target nodes must decrease to normal size (short axis <10 mm). No new lesions. The PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No new lesions. SD was defined as not qualifying for CR, PR, PD. PD is defined using RECIST v1.1 as a 20% increase in the sum of of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. In this outcome measure, DC/CBR was based on BICR. Randomization up to 65 months
Secondary Overall Survival (OS) OS was 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. OS was assessed using Kaplan-Meier methods. Randomization up to 65 months
Secondary 1-Year, 2-Year and 3-Year Survival Probability OS was 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. The 1-year survival probability was estimated using the Kaplan-Meier method and a 2-sided 95% confidence interval (CI) for the log [-log(1 year survival probability)] was be calculated using a normal approximation, and then back transformed to give a CI for the 1-year survival probability itself. The 2-year, and 3-year survival probabilities were estimated similarly. Randomization up to 65 months
Secondary Number of Participants With Treatment-Emergent Adverse Events (All Causalities) An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Participants were counted only once per treatment in each row. Randomization up to 65 months
Secondary Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to treatment was assessed by the investigator (Yes/No). Participants were counted only once per treatment in each row. Randomization up to 65 months
Secondary Number of Participants With Postbaseline Laboratory Abnormalities of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 (Participants With Baseline Laboratory Abnormalities of CTCAE Grade <=2) - Hematology The laboratory results were graded according to the National Cancer Institute (NCI) CTCAE v4.0 severity grade. Shift tables were provided to examine the distribution of laboratory toxicities. The following hematology parameters had met the criteria of CTCAE grade shift change from Grade <=2 at baseline to Grade 3 or 4 post baseline: neutrophils (absolute), white blood cells, platelets, anemia and hemoglobin increased. Randomization up to 65 months
Secondary Number of Participants With Postbaseline Laboratory Abnormalities of Common Terminology Criteria for Adverse Events(CTCAE) Grade 3 or 4 (Participants With Baseline Laboratory Abnormalities of CTCAE Grade <=2) - Chemistry The laboratory results were graded according to the National Cancer Institute (NCI) CTCAE v4.0 severity grade. Shift tables were provided to examine the distribution of laboratory toxicities. The following chemistry parameters had met the criteria of CTCAE grade shift change from Grade <=2 at baseline to Grade 3 or 4 post baseline: alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, and hyponatremia. Randomization up to 65 months
Secondary Trough Plasma Concentration of Palbociclib Summary of palbociclib trough concentrations Pre-dose on Day 14 of Cycle 1 and Cycle 2
Secondary Model Estimated Mean Change From Baseline in Euro Quality of Life 5-Dimension Scale (EQ-5D) Index Scores The EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/depression); a participant was asked to rate each state on a 3 level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/impairment. Baseline up to Cycle 65 Day 1
Secondary Model Estimated Mean Change From Baseline in Euro Quality of Life (EQ) Visual Analog Scale (VAS) Scores The EQ VAS recorded the participant's self rated questionnaire to assess generic health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). Published weights were available that allow for the creation of a single summary score. Baseline up to Cycle 65 Day 1
Secondary Model Estimated Mean Changes From Baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) Total Score The Functional Assessment of Cancer Therapy (FACT) is a modular approach to assess participant health related quality of life using a "core" set of questions (FACT-G) as well as a cancer site specific module. The FACT-G was a 27-item compilation of general questions divided into 4 domains: Physical Well Being, Social/Family Well Being, Emotional Well Being, and Functional Well Being. The FACT-B consists of the FACT-G (27 items) and a breast specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a 5-level scale ranging from 0=Not at all to 4=Very much. FACT-B total score = FACT-G + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-148, with 0 being the worst possible score and 148 the best. A positive change of the total score indicated improvement from baseline and a negative change indicated deterioration. Baseline up to Cycle 65 Day 1
Secondary Median Baseline Percent (%) Positive Cells for Ki67 Archived formalin-fixed paraffin embedded (FFPE) specimen from the original diagnostic tumor tissue was collected and sent to the sponsor-designated central laboratories for assessment of Ki67 associated with sensitivity and/or resistance to Palbociclib. Baseline
Secondary Number of Participants With Detection in Estrogen Receptor (ER) Archived formalin-fixed paraffin embedded (FFPE) specimen from the original diagnostic tumor tissue was collected and sent to the sponsor-designated central laboratories for assessment of ER associated with sensitivity and/or resistance to Palbociclib. Baseline
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