NCT01288092

Brief Summary

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

3.5 years

First QC Date

January 19, 2011

Last Update Submit

June 5, 2012

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancerHER2 negativeHR positivePI3K pathwayno more than 2 prior lines of chemotherapyMetastatic Breast Cancer(MBC)

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival rate after 16 weeks of treatment

    16 weeks after the first BEZ235 administration

Secondary Outcomes (5)

  • determine the efficacy of BEZ235 (objective response rate)

    about 6 months

  • evaluate the clinical benefit rate of BEZ235

    about 6 months

  • evaluate the time to response

    about 6 months

  • evaluate the Progression Free Survival Rate at 16-week & 24-week using the Kaplan-Meier method

    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)

    30-35 days after treatment discontinuation

Study Arms (1)

BEZ235

EXPERIMENTAL
Drug: BEZ235

Interventions

BEZ235DRUG
BEZ235

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dactolisib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

  • Novartis Pharmaceuticals

    Novartis Investigative Site

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2011

First Posted

February 2, 2011

Study Start

March 1, 2012

Primary Completion

September 1, 2015

Last Updated

June 7, 2012

Record last verified: 2012-06