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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01740427




Registration number
NCT01740427
Ethics application status
Date submitted
26/11/2012
Date registered
4/12/2012
Date last updated
14/11/2024

Titles & IDs
Public title
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
Scientific title
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE
Secondary ID [1] 0 0
2012-004601-27
Secondary ID [2] 0 0
A5481008
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PD-0332991
Treatment: Drugs - Letrozole
Treatment: Drugs - Placebo
Treatment: Drugs - Letrozole

Experimental: PD-0332991 + Letrozole - PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).

Active comparator: Placebo + Letrozole - Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).


Treatment: Drugs: PD-0332991
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Treatment: Drugs: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)

Treatment: Drugs: Placebo
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Treatment: Drugs: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
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 (up to approximately 2.5 years)
Secondary outcome [1] 0 0
Objective Response as Assessed by the Investigator
Timepoint [1] 0 0
From randomization until end of treatment (up to approximately 2.5 years)
Secondary outcome [2] 0 0
Objective Response: Participants With Measurable Disease at Baseline as Assessed by the Investigator
Timepoint [2] 0 0
From randomization until end of treatment (up to approximately 2.5 years)
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
From randomization until end of treatment (up to approximately 2.5 years)
Secondary outcome [4] 0 0
Disease Control (DC)/Clinical Benefit Response (CBR)
Timepoint [4] 0 0
From randomization until end of treatment (up to approximately 2.5 years)
Secondary outcome [5] 0 0
PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)
Timepoint [5] 0 0
From randomization until end of treatment (up to approximately 24 Months)
Secondary outcome [6] 0 0
Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14
Timepoint [6] 0 0
Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14
Secondary outcome [7] 0 0
Percentage of Participants With Corrected QT Interval (QTc)
Timepoint [7] 0 0
For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10 (ECGs beyond Cycle 10 were performed as clinically indicated)
Secondary outcome [8] 0 0
Observed Plasma Trough Concentration (Ctrough) at Steady-State
Timepoint [8] 0 0
0 hour (predose) on Day 14 of cycles 1 and 2
Secondary outcome [9] 0 0
Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index
Timepoint [9] 0 0
From Baseline up to 2.5 years
Secondary outcome [10] 0 0
Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)
Timepoint [10] 0 0
From Baseline up to 2.5 years
Secondary outcome [11] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs): All Causalities
Timepoint [11] 0 0
From date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)
Secondary outcome [12] 0 0
Overall Survival (OS): Primary Analysis
Timepoint [12] 0 0
From date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)
Secondary outcome [13] 0 0
Overall Survival (OS): Final Analysis
Timepoint [13] 0 0
From date of randomization until death due to any cause or censored (final analysis till study completion, approximately up to 10.51 years)
Secondary outcome [14] 0 0
Survival Probability at 1 Year, 2 Year and 3 Year
Timepoint [14] 0 0
1, 2 and 3 years after randomization
Secondary outcome [15] 0 0
Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade
Timepoint [15] 0 0
From randomization up to 28 days after last dose of study drug (assessed up to analysis date of 15-Nov-2021, approximately 8.7 years)

Eligibility
Key inclusion criteria
* Adult 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] 0-2
* Adequate organ and marrow function
* Patient must agree to provide tumor tissue
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 (neo)adjuvant treatment with letrozole or anastrozole with DFI = 12-months from completion of treatment.
* Prior treatment with any CDK 4/6 inhibitor.

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 assessing the outcomes
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
22/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/11/2023
Sample size
Target
Accrual to date
Final
666
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Laverty Pathology - Port Macquarie
Recruitment hospital [3] 0 0
Mid North Coast Diagnostic Imaging - Port Macquarie
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Icon Cancer Care - Auchenflower
Recruitment hospital [6] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [7] 0 0
Icon Cancer Care Corporate Office - South Brisbane
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Bendigo Health Care Group, The Bendigo Hospital Campus - Bendigo
Recruitment hospital [11] 0 0
Northern Hospital - Epping
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [13] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [14] 0 0
Maroondah Hospital - Ringwood East
Recruitment hospital [15] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [16] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3550 - Bendigo
Recruitment postcode(s) [10] 0 0
3076 - Epping
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment postcode(s) [12] 0 0
3121 - Richmond
Recruitment postcode(s) [13] 0 0
3135 - Ringwood East
Recruitment postcode(s) [14] 0 0
3630 - Shepparton
Recruitment postcode(s) [15] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
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State/province [3] 0 0
Connecticut
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Kentucky
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Michigan
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Mississippi
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Nebraska
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Tennessee
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Virginia
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West Virginia
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Wisconsin
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Belgium
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Antwerpen
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Belgium
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Brussel
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Charleroi
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Leuven
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Waterford
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BO
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FC
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Milan
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Roma
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Sora (FR)
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Aichi
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Chiba
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Ehime
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Hokkaido
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Kumamoto
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Tokyo
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Fukuoka
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Hiroshima
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Japan
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Iwate
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Kagoshima
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Japan
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Niigata
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Japan
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Osaka
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Korea, Republic of
State/province [92] 0 0
Gyeonggi-do
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Korea, Republic of
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Seoul
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Poland
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Mazovia
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Gdansk
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Poland
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Zory
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Kursk Region
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Russian Federation
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Leningrad Region
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Russian Federation
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Kazan
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Russian Federation
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Moscow Area
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Moscow
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Omsk
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Ryazan
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Saint-Petersburg
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Russian Federation
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St Petersburg
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Russian Federation
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Ufa
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Spain
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Barcelona
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Spain
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Islas Baleares
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Spain
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Madrid
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Spain
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Santa CRUZ DE Tenerife
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Spain
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Badajoz
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Spain
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Donostia- San Sebastian
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Spain
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Jaen
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Spain
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L'Hospitalet De Llobregat (Barcelona)
Country [115] 0 0
Spain
State/province [115] 0 0
La Coruna
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Spain
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Lleida
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Spain
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Sevilla
Country [118] 0 0
Spain
State/province [118] 0 0
Valencia
Country [119] 0 0
Taiwan
State/province [119] 0 0
Taipei City
Country [120] 0 0
Taiwan
State/province [120] 0 0
Taipei
Country [121] 0 0
Ukraine
State/province [121] 0 0
Dnipro
Country [122] 0 0
Ukraine
State/province [122] 0 0
Kharkiv
Country [123] 0 0
Ukraine
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Lviv
Country [124] 0 0
Ukraine
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Makiivka
Country [125] 0 0
Ukraine
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Sumy
Country [126] 0 0
Ukraine
State/province [126] 0 0
Uzhgorod
Country [127] 0 0
Ukraine
State/province [127] 0 0
Zaporizhzhia
Country [128] 0 0
Ukraine
State/province [128] 0 0
Zaporizhzhya
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Kent
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Scotland
Country [131] 0 0
United Kingdom
State/province [131] 0 0
London
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
Trial website
https://clinicaltrials.gov/study/NCT01740427
Trial related presentations / publications
Zhu Z, Turner NC, Loi S, Andre F, Martin M, Dieras V, Gelmon KA, Harbeck N, Zhang C, Cao JQ, Yan Z, Lu DR, Wei P, VanArsdale TL, Rejto PA, Huang X, Rugo HS, Loibl S, Cristofanilli M, Finn RS, Liu Y. Comparative biomarker analysis of PALOMA-2/3 trials for palbociclib. NPJ Precis Oncol. 2022 Aug 16;6(1):56. doi: 10.1038/s41698-022-00297-1.
Gelmon K, Walshe JM, Mahtani R, Joy AA, Karuturi M, Neven P, Lu DR, Kim S, Schnell P, Bananis E, Schwartzberg L. Efficacy and safety of palbociclib in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2. Breast. 2021 Oct;59:321-326. doi: 10.1016/j.breast.2021.07.017. Epub 2021 Jul 28.
Iwata H, Umeyama Y, Liu Y, Zhang Z, Schnell P, Mori Y, Fletcher O, Marshall JC, Johnson JG, Wood LS, Toi M, Finn RS, Turner NC, Bartlett CH, Cristofanilli M. Evaluation of the Association of Polymorphisms With Palbociclib-Induced Neutropenia: Pharmacogenetic Analysis of PALOMA-2/-3. Oncologist. 2021 Jul;26(7):e1143-e1155. doi: 10.1002/onco.13811. Epub 2021 Jun 7.
Finn RS, Rugo HS, Gelmon KA, Cristofanilli M, Colleoni M, Loi S, Schnell P, Lu DR, Theall KP, Mori A, Gauthier E, Bananis E, Turner NC, Dieras V. Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. Oncologist. 2021 May;26(5):e749-e755. doi: 10.1002/onco.13684. Epub 2021 Mar 10.
Zheng J, Yu Y, Durairaj C, Dieras V, Finn RS, Wang DD. Impact of Dose Reduction on Efficacy: Implications of Exposure-Response Analysis of Palbociclib. Target Oncol. 2021 Jan;16(1):69-76. doi: 10.1007/s11523-020-00771-5.
Finn RS, Cristofanilli M, Ettl J, Gelmon KA, Colleoni M, Giorgetti C, Gauthier E, Liu Y, Lu DR, Zhang Z, Bartlett CH, Slamon DJ, Turner NC, Rugo HS. Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials. Breast Cancer Res Treat. 2020 Nov;184(1):23-35. doi: 10.1007/s10549-020-05782-4. Epub 2020 Aug 11.
Huang Bartlett C, Mardekian J, Cotter MJ, Huang X, Zhang Z, Parrinello CM, Bourla AB. Concordance of real-world versus conventional progression-free survival from a phase 3 trial of endocrine therapy as first-line treatment for metastatic breast cancer. PLoS One. 2020 Apr 21;15(4):e0227256. doi: 10.1371/journal.pone.0227256. eCollection 2020.
Ettl J, Im SA, Ro J, Masuda N, Colleoni M, Schnell P, Bananis E, Lu DR, Cristofanilli M, Rugo HS, Finn RS. Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies. Breast Cancer Res. 2020 Mar 12;22(1):27. doi: 10.1186/s13058-020-01263-0.
Rugo HS, Finn RS, Gelmon K, Joy AA, Harbeck N, Castrellon A, Mukai H, Walshe JM, Mori A, Gauthier E, Lu DR, Bananis E, Martin M, Dieras V. Progression-free Survival Outcome Is Independent of Objective Response in Patients With Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer Treated With Palbociclib Plus Letrozole Compared With Letrozole: Analysis From PALOMA-2. Clin Breast Cancer. 2020 Apr;20(2):e173-e180. doi: 10.1016/j.clbc.2019.08.009. Epub 2019 Sep 5.
Dieras V, Harbeck N, Joy AA, Gelmon K, Ettl J, Verma S, Lu DR, Gauthier E, Schnell P, Mori A, Rugo HS, Finn RS. Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2- Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA-2 Trial. Oncologist. 2019 Dec;24(12):1514-1525. doi: 10.1634/theoncologist.2019-0019. Epub 2019 Jun 19.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01740427