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This study has been withdrawn prior to enrollment.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01288092
First received: January 19, 2011
Last updated: June 5, 2012
Last verified: June 2012
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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: 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01288092
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
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov 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 Breast Diseases Neoplasms Neoplasms by Site Skin Diseases |
ClinicalTrials.gov processed this record on February 27, 2015