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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01942135




Registration number
NCT01942135
Ethics application status
Date submitted
10/09/2013
Date registered
13/09/2013

Titles & IDs
Public title
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
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
Secondary ID [1] 0 0
2013-002580-26
Secondary ID [2] 0 0
A5481023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by the Investigator
Timepoint [1] 0 0
From randomization date to date of first documentation of progression or death (assessed up to 12 months)
Secondary outcome [1] 0 0
Overall Survival (OS)-Number of Participants Who Died
Timepoint [1] 0 0
From randomization until death (up to 4.5 years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization until death (up to 4.5 years)
Secondary outcome [3] 0 0
Survival Probabilities at Year 1, Year 2, and Year 3
Timepoint [3] 0 0
From randomization until death (assessed up to 36 months)
Secondary outcome [4] 0 0
Objective Response (OR)
Timepoint [4] 0 0
From randomization until end of treatment (assessed up to 2 years)
Secondary outcome [5] 0 0
Duration of Response (DR)
Timepoint [5] 0 0
From randomization until end of treatment (assessed up to 2 years)
Secondary outcome [6] 0 0
Clinical Benefit Response (CBR)
Timepoint [6] 0 0
From randomization until end of treatment (assessed up to 2 years)
Secondary outcome [7] 0 0
Observed Plasma Trough Concentration (Ctrough) for Palbociclib
Timepoint [7] 0 0
Cycle 1/Day 15 and Cycle 2/Day 15
Secondary outcome [8] 0 0
Ctrough for Fulvestrant
Timepoint [8] 0 0
Cycles 2/Day 1 and Cycle 3/Day 1
Secondary outcome [9] 0 0
Ctrough for Goserelin
Timepoint [9] 0 0
Cycles 2/ Day 1 and Cycle 3/ Day 1
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
From Cycle 1 to 14, as of 05 December 2014.
Secondary outcome [11] 0 0
Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores
Timepoint [11] 0 0
From Cycle 1 to 14, as of 05 December 2014.
Secondary outcome [12] 0 0
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
Timepoint [12] 0 0
From Cycle 1 to 14, as of 05 December 2014.
Secondary outcome [13] 0 0
Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores
Timepoint [13] 0 0
From Cycle 1 to 14, as of 05 December 2014.
Secondary outcome [14] 0 0
Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores
Timepoint [14] 0 0
From Cycle 1 to 14, as of 05 December 2014.
Secondary outcome [15] 0 0
Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale
Timepoint [15] 0 0
From Cycle 1 to 14, as of 05 December 2014.
Secondary outcome [16] 0 0
Time to Deterioration (TTD)
Timepoint [16] 0 0
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
Secondary outcome [17] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)
Timepoint [17] 0 0
From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).
Secondary outcome [18] 0 0
Participants With Shifts From CTCAE Grade =2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Hematology Results
Timepoint [18] 0 0
From baseline to end of treatment/withdrawal (up to 4.5 years)
Secondary outcome [19] 0 0
Participants With Shifts From CTCAE Grade =2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Chemistry Results
Timepoint [19] 0 0
From baseline to end of treatment/withdrawal (up to 4.5 years)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2022
Sample size
Target
Accrual to date
Final
521
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Bankstown - Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [4] 0 0
Sunshine Coast Hospital and Health Service - Nambour
Recruitment hospital [5] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [6] 0 0
Cabrini Brighton - Brighton
Recruitment hospital [7] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
Peninsula and Southeast Oncology - Frankston
Recruitment hospital [9] 0 0
Barwon Health, University Hospital Geelong - Geelong
Recruitment hospital [10] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre Pharmacy - Melbourne
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [13] 0 0
Sunshine Hospital Clinical Trials Pharmacy - St Albans
Recruitment hospital [14] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [15] 0 0
Fiona Stanley Hospital - Cancer Centre - Murdoch
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4560 - Nambour
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3186 - Brighton
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
3000 - Melbourne
Recruitment postcode(s) [12] 0 0
3021 - St Albans
Recruitment postcode(s) [13] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Belgium
State/province [24] 0 0
Antwerpen
Country [25] 0 0
Belgium
State/province [25] 0 0
Brabant Wallon
Country [26] 0 0
Belgium
State/province [26] 0 0
Bruxelles Capitale
Country [27] 0 0
Belgium
State/province [27] 0 0
Hainaut
Country [28] 0 0
Belgium
State/province [28] 0 0
Luxembourg
Country [29] 0 0
Belgium
State/province [29] 0 0
Region DE Bruxelles-capital
Country [30] 0 0
Belgium
State/province [30] 0 0
Bonheiden
Country [31] 0 0
Belgium
State/province [31] 0 0
Bruxelles
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Belgium
State/province [33] 0 0
Namur
Country [34] 0 0
Belgium
State/province [34] 0 0
Wilrijk
Country [35] 0 0
Canada
State/province [35] 0 0
British Columbia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Germany
State/province [38] 0 0
Leipzig
Country [39] 0 0
Germany
State/province [39] 0 0
München
Country [40] 0 0
Ireland
State/province [40] 0 0
Cork
Country [41] 0 0
Italy
State/province [41] 0 0
Bagno A Ripoli (FI)
Country [42] 0 0
Italy
State/province [42] 0 0
Bologna
Country [43] 0 0
Italy
State/province [43] 0 0
Catania
Country [44] 0 0
Italy
State/province [44] 0 0
Legnago (VR)
Country [45] 0 0
Italy
State/province [45] 0 0
Meldola (FC)
Country [46] 0 0
Italy
State/province [46] 0 0
Milano
Country [47] 0 0
Italy
State/province [47] 0 0
Modena
Country [48] 0 0
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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Japan
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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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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
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Netherlands
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Limburg
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Netherlands
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Noord-brabant
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Netherlands
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Zuid-holland
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Bucharest
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Romania
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Ploiesti
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Romania
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Suceava
Country [68] 0 0
Romania
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Tg. Mures
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Belgorodskaya Oblast',
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Belgorodskaya Oblast'
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Leningradskaya Oblast'
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Republic OF Bashkortostan
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Stavropol Territory
Country [74] 0 0
Russian Federation
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Chelyabinsk
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Moscow
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Saint Petersburg
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Stavropol
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Village Pesochny
Country [79] 0 0
Taiwan
State/province [79] 0 0
Tainan
Country [80] 0 0
Taiwan
State/province [80] 0 0
Taipei
Country [81] 0 0
Turkey
State/province [81] 0 0
Bornova
Country [82] 0 0
Ukraine
State/province [82] 0 0
Chernivtsi
Country [83] 0 0
Ukraine
State/province [83] 0 0
Dnipro
Country [84] 0 0
Ukraine
State/province [84] 0 0
Kharkiv
Country [85] 0 0
Ukraine
State/province [85] 0 0
Lviv
Country [86] 0 0
Ukraine
State/province [86] 0 0
Odesa
Country [87] 0 0
Ukraine
State/province [87] 0 0
Vinnytsia
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Hampshire
Country [89] 0 0
United Kingdom
State/province [89] 0 0
South Glamorgan
Country [90] 0 0
United Kingdom
State/province [90] 0 0
South Yorkshire
Country [91] 0 0
United Kingdom
State/province [91] 0 0
London
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01942135