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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02513394
Ethics application status
Date submitted
29/07/2015
Date registered
31/07/2015
Date last updated
11/02/2019

Titles & IDs
Public 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
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
Treatment: Drugs - Palbociclib
Treatment: Drugs - Standard Adjuvant Endocrine Therapy

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.


Treatment: Drugs: Palbociclib


Treatment: Drugs: Standard Adjuvant Endocrine Therapy


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease Free Survival (iDFS) - To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC).
Timepoint [1] 0 0
The expected study duration to primary analysis of iDFS is 5.4 years
Secondary outcome [1] 0 0
To compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone. (distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS) - To compare the following endpoints: iDFS excluding second primary cancers of non-breast origin, distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS).
Timepoint [1] 0 0
The expected study duration to primary analysis of iDFS is 5.4 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
CCLHD/Gosford & Wyong Hospitals - Gosford
Recruitment hospital [5] 0 0
Orange Health Service - Orange
Recruitment hospital [6] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [7] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [8] 0 0
Cancer Care Services, Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [9] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
The Northern Hospital - Epping
Recruitment hospital [12] 0 0
St Vincent's Hospital Cancer Centre - Fitzroy
Recruitment hospital [13] 0 0
Barwon Health - Geelong
Recruitment hospital [14] 0 0
Peninsula Health - Frankston Hospital - Melbourne
Recruitment hospital [15] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [16] 0 0
Western Health, Sunshine Hospital - St. Albans
Recruitment hospital [17] 0 0
South West Oncology - Warrnambool
Recruitment hospital [18] 0 0
St John of God Bunbury Hospital - Bunbury
Recruitment hospital [19] 0 0
Fiona Stanley Hospital - Murdoch, Perth
Recruitment hospital [20] 0 0
Breast Cancer Research Centre - Perth
Recruitment postcode(s) [1] 0 0
- Bowral
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Gateshead
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- Gosford
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- Orange
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- Sydney
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- Wollongong
Recruitment postcode(s) [8] 0 0
- Brisbane
Recruitment postcode(s) [9] 0 0
- Bedford Park
Recruitment postcode(s) [10] 0 0
- Hobart
Recruitment postcode(s) [11] 0 0
- Epping
Recruitment postcode(s) [12] 0 0
- Fitzroy
Recruitment postcode(s) [13] 0 0
- Geelong
Recruitment postcode(s) [14] 0 0
- Melbourne
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- St. Albans
Recruitment postcode(s) [16] 0 0
- Warrnambool
Recruitment postcode(s) [17] 0 0
- Bunbury
Recruitment postcode(s) [18] 0 0
- Murdoch, Perth
Recruitment postcode(s) [19] 0 0
- Perth
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Arizona
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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New Mexico
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New York
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North Carolina
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Aichi
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Chiba
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Toluca
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Changhua County
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Kaohsiung
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Tainan
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Taiwan
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Taipei

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/show/NCT02513394
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Monica Bertagnolli, MD
Address 0 0
Alliance Foundation Trials, LLC.
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

Summary results
Other publications