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BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer

Primary Purpose

Metastatic Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BEZ235
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Metastatic breast cancer, HER2 negative, HR positive, PI3K pathway, no more than 2 prior lines of chemotherapy, Metastatic Breast Cancer(MBC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Female ≥ 18 years
  • ECOG performance status ≤ 2
  • Histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and HER2 negative)
  • Known PI3K activation status (defined by PIK3CA (Phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and PTEN PTEN (Phosphatase and Tensin Homolog) mutation/expression)
  • Prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer
  • Objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per RECIST
  • Adequate bone marrow and organ function

Exclusion Criteria:

  • Previous treatment with PI3K and/or mTOR inhibitors
  • Symptomatic Central Nervous System (CNS) metastases
  • Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
  • Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
  • Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) < 50%, QTcF > 480 msec on screening ECGelectrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
  • Inadequately controlled hypertension
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
  • Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists
  • History of photosensitivity reactions to other drugs
  • Pregnant or nursing (lactating) woman

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BEZ235

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progression-free survival rate after 16 weeks of treatment

    Secondary Outcome Measures

    determine the efficacy of BEZ235 (objective response rate)
    evaluate the clinical benefit rate of BEZ235
    evaluate the time to response
    evaluate the Progression Free Survival Rate at 16-week & 24-week using the Kaplan-Meier method
    evaluate safety of BEZ235 (frequency and severity of Adverse Events, abnormal laboratory values, other safety data as appropriate)

    Full Information

    First Posted
    January 19, 2011
    Last Updated
    June 5, 2012
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01288092
    Brief Title
    BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
    Official Title
    A Phase II Study of Orally Administered BEZ235 Monotherapy in Patients With Hormone Receptor Positive, HER2 Negative, Metastatic Breast Cancer, With or Without PI3K Activated Pathway
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2- breast cancer who have received at least one prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic disease. Patients will be stratified into 3 groups according to their PI3K (phosphatidylinositol 3-Kinase) pathway activation status.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Breast Cancer
    Keywords
    Metastatic breast cancer, HER2 negative, HR positive, PI3K pathway, no more than 2 prior lines of chemotherapy, Metastatic Breast Cancer(MBC)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BEZ235
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    BEZ235
    Primary Outcome Measure Information:
    Title
    Progression-free survival rate after 16 weeks of treatment
    Time Frame
    16 weeks after the first BEZ235 administration
    Secondary Outcome Measure Information:
    Title
    determine the efficacy of BEZ235 (objective response rate)
    Time Frame
    about 6 months
    Title
    evaluate the clinical benefit rate of BEZ235
    Time Frame
    about 6 months
    Title
    evaluate the time to response
    Time Frame
    about 6 months
    Title
    evaluate the Progression Free Survival Rate at 16-week & 24-week using the Kaplan-Meier method
    Time Frame
    16-week & 24-week after the first BEZ235 administration
    Title
    evaluate safety of BEZ235 (frequency and severity of Adverse Events, abnormal laboratory values, other safety data as appropriate)
    Time Frame
    30-35 days after treatment discontinuation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female ≥ 18 years ECOG performance status ≤ 2 Histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and HER2 negative) Known PI3K activation status (defined by PIK3CA (Phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and PTEN PTEN (Phosphatase and Tensin Homolog) mutation/expression) Prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer Objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per RECIST Adequate bone marrow and organ function Exclusion Criteria: Previous treatment with PI3K and/or mTOR inhibitors Symptomatic Central Nervous System (CNS) metastases Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) < 50%, QTcF > 480 msec on screening ECGelectrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias) Inadequately controlled hypertension Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists History of photosensitivity reactions to other drugs Pregnant or nursing (lactating) woman Other protocol-defined inclusion/exclusion criteria may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Investigative Site
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer

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