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

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. Read our disclaimer for details. Identifier: NCT01288092
Recruitment Status : Withdrawn
First Posted : February 2, 2011
Last Update Posted : June 7, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: BEZ235 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : March 2012
Estimated Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BEZ235 Drug: BEZ235

Primary Outcome Measures :
  1. Progression-free survival rate after 16 weeks of treatment [ Time Frame: 16 weeks after the first BEZ235 administration ]

Secondary Outcome Measures :
  1. determine the efficacy of BEZ235 (objective response rate) [ Time Frame: about 6 months ]
  2. evaluate the clinical benefit rate of BEZ235 [ Time Frame: about 6 months ]
  3. evaluate the time to response [ Time Frame: about 6 months ]
  4. 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 ]
  5. 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 ]

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

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

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 identifier (NCT number): NCT01288092

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Investigative Site

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01288092     History of Changes
Other Study ID Numbers: CBEZ235B2201
2010-024394-39 ( EudraCT Number )
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 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
Breast Diseases
Skin Diseases
Antineoplastic Agents