Status:
TERMINATED
Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Inoperable Locally Advanced Breast Cancer
Metastatic Breast Cancer (MBC)
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase Ib) will inves...
Eligibility Criteria
Inclusion
- Inclusion Criteria (phase lb):
- Females with Breast cancer that is histologically or cytologically confirmed, HER2 negative and locally advanced or metastatic as confirmed by radiology
- ECOG performance status 0 and 1
- Adequate bone marrow and organ function
- Exclusion Criteria (Phase lb):
- 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. LVEF less than institutional lower limit of normal, QTcF \> 480 msec, 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 and/or paclitaxel
- 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
- Sensitivity to paclitaxel treatment
- Uncontrolled diabetes mellitus
- Pregnant or nursing (lactating) woman
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
January 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01495247
Start Date
January 30 2012
End Date
May 19 2014
Last Update
December 8 2020
Active Locations (3)
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1
Novartis Investigative Site
Dijon, France, 21034
2
Novartis Investigative Site
Saint-Herblain Cédex, France, 44805
3
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain, 08907