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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 19, 2011
Last updated: June 5, 2012
Last verified: June 2012

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: 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:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression-free survival rate after 16 weeks of treatment [ Time Frame: 16 weeks after the first BEZ235 administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • determine the efficacy of BEZ235 (objective response rate) [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
  • evaluate the clinical benefit rate of BEZ235 [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
  • evaluate the time to response [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its identifier: NCT01288092

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01288092     History of Changes
Other Study ID Numbers: CBEZ235B2201, 2010-024394-39
Study First Received: January 19, 2011
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
Columbia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Peru: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
South Africa: Department of Health
Sweden: Medical Products Agency
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
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 processed this record on April 17, 2014