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Withdrawn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

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
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
NCT ID
NCT01288092
First Posted
January 19, 2011
Last Updated
June 5, 2012
Sponsor
Novartis Pharmaceuticals
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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