BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT01288092 |
Recruitment Status
:
Withdrawn
First Posted
: February 2, 2011
Last Update Posted
: June 7, 2012
|
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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 |

Arm | Intervention/treatment |
---|---|
Experimental: BEZ235 | Drug: BEZ235 |
- Progression-free survival rate after 16 weeks of treatment [ Time Frame: 16 weeks after the first BEZ235 administration ]
- 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 ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT01288092
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals | |
Study Director: | Novartis Pharmaceuticals | Novartis Investigative Site |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov 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 Neoplasms Breast Diseases |
Skin Diseases Dactolisib Antineoplastic Agents |