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Trial record 1 of 12 for:    PALLAS
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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 (PALLAS)

This study is currently recruiting participants.
Verified September 2017 by Alliance Foundation Trials, LLC.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02513394
First Posted: July 31, 2015
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Austrian Breast & Colorectal Cancer Study Group
NSABP Foundation Inc
PrECOG, LLC.
Breast International Group
Pfizer
Information provided by (Responsible Party):
Alliance Foundation Trials, LLC.
  Purpose

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.


Condition Intervention Phase
Breast Cancer Drug: Palbociclib Drug: Standard Adjuvant Endocrine Therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Alliance Foundation Trials, LLC.:

Primary Outcome Measures:
  • Invasive Disease Free Survival (iDFS) [ Time Frame: The expected study duration to primary analysis of iDFS is 4.8 years ]
    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).


Secondary Outcome Measures:
  • 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) [ Time Frame: The expected study duration to primary analysis of iDFS is 4.8 years ]
    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).


Estimated Enrollment: 4600
Study Start Date: August 2015
Estimated Study Completion Date: September 2025
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Palbociclib Drug: Standard Adjuvant Endocrine Therapy
Arm B
Standard adjuvant endocrine therapy for a duration of at least 5 years.
Drug: Standard Adjuvant Endocrine Therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.

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 (for exceptions see: Pallas -

  • Protocol, v1.0, Exclusion criteria 8).
  • Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
  • Patients on combination antiretroviral therapy.
  • Patients with clinically significant history of any liver disease.
  • Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513394


Contacts
Contact: Edward Habermehl info@alliancefoundationtrials.org

  Show 229 Study Locations
Sponsors and Collaborators
Alliance Foundation Trials, LLC.
Austrian Breast & Colorectal Cancer Study Group
NSABP Foundation Inc
PrECOG, LLC.
Breast International Group
Pfizer
Investigators
Principal Investigator: Monica Bertagnolli, MD Alliance Foundation Trials, LLC.
Principal Investigator: Erica Mayer, MD Dana-Farber Cancer Institute
Principal Investigator: Angela DeMichele, MD University of Pennsylvania
Principal Investigator: Michael Gnant, MD ABCSG, Medical University Vienna
  More Information

Responsible Party: Alliance Foundation Trials, LLC.
ClinicalTrials.gov Identifier: NCT02513394     History of Changes
Other Study ID Numbers: AFT-05
ABCSG 42 ( Other Identifier: ABCSG GmbH )
BIG 14-03 ( Other Identifier: Breast International Group )
2014-005181-30 ( EudraCT Number )
First Submitted: July 29, 2015
First Posted: July 31, 2015
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Alliance Foundation Trials, LLC.:
HR+/HER2- breast cancer
Palbociclib

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Mitogens
Palbociclib
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors