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

Purpose

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.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: BEZ235	Phase 2


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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:

Progression-free survival rate after 16 weeks of treatment [ Time Frame: 16 weeks after the first BEZ235 administration ]

Secondary Outcome Measures:

determine the efficacy of BEZ235 (objective response rate) [ Time Frame: about 6 months ]
evaluate the clinical benefit rate of BEZ235 [ Time Frame: about 6 months ]
evaluate the time to response [ Time Frame: about 6 months ]
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 ]
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 ]


Enrollment:	0
Study Start Date:	March 2012
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BEZ235	Drug: BEZ235

Eligibility


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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288092

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals
Study Director:	Novartis Pharmaceuticals	Novartis Investigative Site

More Information


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01288092 History of Changes
Other Study ID Numbers:	CBEZ235B2201 2010-024394-39 ( EudraCT Number )
Study First Received:	January 19, 2011
Last Updated:	June 5, 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Metastatic breast cancer HER2 negative HR positive	PI3K pathway no more than 2 prior lines of chemotherapy Metastatic Breast Cancer(MBC)

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

ClinicalTrials.gov processed this record on August 17, 2017