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A Dose-finding Phase Ib Study Followed by an Open-label, Randomized Phase II Study of BEZ235 Plus Paclitaxel in Patients With HER2 Negative, Inoperable Locally Advanced or Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Inoperable Locally Advanced Breast Cancer, Metastatic Breast Cancer (MBC)

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Trial Information

A Dose-finding Phase Ib Study Followed by an Open-label, Randomized Phase II Study of BEZ235 Plus Paclitaxel in Patients With HER2 Negative, Inoperable Locally Advanced or Metastatic Breast Cancer

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase lb: Dose Limiting Toxicities (DLTs) the first cycle of treatment

Outcome Description:

DLT is defined as treatment-related toxicity (classified according Common Toxicity Criteria for Adverse Events (CTCAE) Version 4) occurring during the first 28 treatment days and meeting specific protocol-predefined criteria. The information will be integrated in a Bayesian logistic regression model with overdose control to estimate the maximum tolerated dose (MTD).

Outcome Time Frame:

At first treatment intake (Cycle 1 Day 1 = C1D1), C1D8, C1D15, C1D22 and C2D1 [a cycle = 4 weeks = 28 days]

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBEZ235B2101

NCT ID:

NCT01495247

Start Date:

January 2012

Completion Date:

April 2015

Related Keywords:

  • Inoperable Locally Advanced Breast Cancer
  • Metastatic Breast Cancer (MBC)
  • Locally advanced
  • metastatic
  • breast cancer
  • HER2 negative
  • PI3K pathway
  • paclitaxel
  • mTOR inhibitor
  • Breast Neoplasms

Name

Location

Highlands Oncology GroupSpringdale, Arkansas  72764
US Oncology Central MonitoringDallas, Texas  75246
Ironwood Cancer and Research Centers IronwoodChandler, Arizona  85224
Texas Oncology, P.A. Dept.ofTexas Oncology, PADallas, Texas  75246