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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02513394




Registration number
NCT02513394
Ethics application status
Date submitted
29/07/2015
Date registered
31/07/2015
Date last updated
24/01/2024

Titles & IDs
Public title
PALbociclib CoLlaborative Adjuvant Study
Scientific title
PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer
Secondary ID [1] 0 0
ABCSG 42
Secondary ID [2] 0 0
AFT-05
Universal Trial Number (UTN)
Trial acronym
PALLAS
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Arm A - Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.

Other: Arm B - Standard adjuvant endocrine therapy for a duration of at least 5 years.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease Free Survival (iDFS)
Timepoint [1] 0 0
4 years
Secondary outcome [1] 0 0
Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin.
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Distant Recurrence-free Survival (DRFS)
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
Locoregional Recurrences-free Survival (LRRFS)
Timepoint [4] 0 0
4 years

Eligibility
Key inclusion criteria
* Signed informed consent prior to study specific procedures.
* Age =18 years (or per national guidelines).
* Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer
* Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and/or PR+ and HER2-.
* Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive breast cancer.
* Patients must have undergone adequate (definitive) breast surgery for the current malignancy.

FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.

* ECOG performance status 0-1.
* Patients must be able and willing to swallow and retain oral medication.
* Serum or urine pregnancy test must be negative in premenopausal women within 14 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization.
* Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
* Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects.
* Patients must have sufficient resolution of any surgical side effects (no active wound healing complications).

-Patients must either be initiating or have already started adjuvant hormonal treatment. -

* Patients who already received neo/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy.
* Absolute neutrophil count = 1,500/µL
* Platelets = 100,000/ mm3
* Hemoglobin = 10g/dL
* Total serum bilirubin = ULN; or total bilirubin = 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
* Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) = 1.5 × institutional ULN.
* Serum creatinine below the upper limit of the institutional normal range (ULN) or creatinine clearance = 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concurrent therapy with other Investigational Products.
* Prior therapy with any CDK inhibitor.
* Patients with Stage I or IV breast cancer are not eligible.
* History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
* Patients receiving any medications or substances that are potent inhibitors or inducers of
* CYP3A isoenzymes within 7 days of randomization.
* Uncontrolled intercurrent illness that would limit compliance with study requirements.
* Pregnant women, or women of childbearing potential without a negative pregnancy test within 14 days prior to randomization.
* Patients with a history of any malignancy are ineligible
* Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
* Patients on antiretroviral therapy.
* Patients with clinically significant history of any chronic liver disease.
* Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
Accrual to date
Final
5796
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Southern Highlands Cancer Centre - Bowral
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus - MNCCI - Coffs Harbour
Recruitment hospital [3] 0 0
The Breast & Endocrine Centre - Gateshead
Recruitment hospital [4] 0 0
Gosford Hospital - Gosford
Recruitment hospital [5] 0 0
Macquarie University Hospital - Macquarie Park
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Orange Health Service - Orange
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Wollongong Hospital - Wollongong
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Royal Brisbane & Women's Hospital - Brisbane
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Flinders Drive - Bedford Park
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Royal Hobart Hospital - Hobart
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The Northern Hospital - Epping
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St Vincent's Hospital - Fitzroy
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Peninsula Health - Frankston Hospital - Frankston
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University Hospital, Geelong - Geelong
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Peter MacCallum Cancer Centre - Melbourne
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Peninsula Health - Frankston Hospital - Melbourne
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Western Health, Sunshine Hospital - St. Albans
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South West Healthcare, Warrnambool - Warrnambool
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St John of God Bunbury Hospital - Bunbury
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Fiona Stanley Hospital - Murdoch
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Breast Cancer Research Centre - WA - Nedlands
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2576 - Bowral
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2450 - Coffs Harbour
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2290 - Gateshead
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2500 - Gosford
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2109 - Macquarie Park
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2800 - Orange
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2500 - Wollongong
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4029 - Brisbane
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5042 - Bedford Park
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7000 - Hobart
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3076 - Epping
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3065 - Fitzroy
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3199 - Frankston
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3000 - Melbourne
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- Melbourne
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3021 - St. Albans
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3280 - Warrnambool
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6231 - Bunbury
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- Murdoch
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6009 - Nedlands
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Maidstone
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United Kingdom
State/province [199] 0 0
Manchester
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Newcastle upon Tyne
Country [201] 0 0
United Kingdom
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Nottingham
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Sheffield
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United Kingdom
State/province [203] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Other
Name
Alliance Foundation Trials, LLC.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austrian Breast & Colorectal Cancer Study Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
NSABP Foundation Inc
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
PrECOG, LLC.
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Breast International Group
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/industry
Name [5] 0 0
Pfizer
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC).

The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.
Trial website
https://clinicaltrials.gov/study/NCT02513394
Trial related presentations / publications
Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). J Clin Oncol. 2022 Feb 10;40(5):449-458. doi: 10.1200/JCO.21.01918. Epub 2022 Jan 7.
Gnant M, Dueck AC, Frantal S, Martin M, Burstein HJ, Greil R, Fox P, Wolff AC, Chan A, Winer EP, Pfeiler G, Miller KD, Colleoni M, Suga JM, Rubovsky G, Bliss JM, Mayer IA, Singer CF, Nowecki Z, Hahn O, Thomson J, Wolmark N, Amillano K, Rugo HS, Steger GG, Hernando Fernandez de Aranguiz B, Haddad TC, Perello A, Bellet M, Fohler H, Metzger Filho O, Jallitsch-Halper A, Solomon K, Schurmans C, Theall KP, Lu DR, Tenner K, Fesl C, DeMichele A, Mayer EL; PALLAS groups and investigators. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03). J Clin Oncol. 2022 Jan 20;40(3):282-293. doi: 10.1200/JCO.21.02554. Epub 2021 Dec 7.
Mayer EL, Dueck AC, Martin M, Rubovszky G, Burstein HJ, Bellet-Ezquerra M, Miller KD, Zdenkowski N, Winer EP, Pfeiler G, Goetz M, Ruiz-Borrego M, Anderson D, Nowecki Z, Loibl S, Moulder S, Ring A, Fitzal F, Traina T, Chan A, Rugo HS, Lemieux J, Henao F, Lyss A, Antolin Novoa S, Wolff AC, Vetter M, Egle D, Morris PG, Mamounas EP, Gil-Gil MJ, Prat A, Fohler H, Metzger Filho O, Schwarz M, DuFrane C, Fumagalli D, Theall KP, Lu DR, Bartlett CH, Koehler M, Fesl C, DeMichele A, Gnant M. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021 Feb;22(2):212-222. doi: 10.1016/S1470-2045(20)30642-2. Epub 2021 Jan 15.
Dieras V, Rugo HS, Schnell P, Gelmon K, Cristofanilli M, Loi S, Colleoni M, Lu DR, Mori A, Gauthier E, Huang Bartlett C, Slamon DJ, Turner NC, Finn RS. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. J Natl Cancer Inst. 2019 Apr 1;111(4):419-430. doi: 10.1093/jnci/djy109.
Public notes

Contacts
Principal investigator
Name 0 0
Evanthia Galanis, MD
Address 0 0
Alliance Foundation Trials, LLC.
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02513394