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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

NCT02513394

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">PALbociclib</span> CoLlaborative Adjuvant Study: A Randomized Phase III Trial of <span class="go-doc-concept go-doc-intervention">Palbociclib</span> With <span class="go-doc-concept go-doc-intervention">Standard Adjuvant Endocrine Therapy</span> Versus <span class="go-doc-concept go-doc-intervention">Standard Adjuvant Endocrine Therapy</span> Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (<span class="go-doc-concept go-doc-biomarker">HER2</span>)-Negative Early <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief 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
  • 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
  • Clinical Trial IDs

    NCT ID: NCT02513394

    ORG ID: AFT-05

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Palbociclib Arm A
    Standard Adjuvant Endocrine Therapy Arm A, Arm B

    Trial 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm A Experimental 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. Palbociclib, Standard Adjuvant Endocrine Therapy
    Arm B Other Standard adjuvant endocrine therapy for a duration of at least 5 years. Standard Adjuvant Endocrine Therapy

    Eligibility Criteria

    Inclusion Criteria:

    - Signed informed consent prior to study specific precedures.

    - 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/L

    - 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).

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Invasive Disease Free Survival (iDFS)

    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)

    Trial Keywords

    HR+/HER2- breast cancer

    Palbociclib