Trial record 1 of 1 for:    NCT01572727
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A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation (BELLE-4)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01572727
First received: April 4, 2012
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Paclitaxel
Drug: BKM120 matching placebo
Drug: BKM120
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • progression free survival (PFS) [ Time Frame: Every 8 weeks after randomization ] [ Designated as safety issue: No ]
    PFS is defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment


Secondary Outcome Measures:
  • overall survival [ Time Frame: Every 3 months after end of Treatment ] [ Designated as safety issue: No ]
    Time from date of randomization to the date of death from any cause

  • overall response rate [ Time Frame: Every 8 weeks after randomization ] [ Designated as safety issue: No ]
    Proportion of patients with best overall response of complete response (CR) or partial response (PR) based according to RECIST 1.1

  • duration of response [ Time Frame: Every 8 weeks after randomization ] [ Designated as safety issue: No ]
    time from the date of the first documented response (CR or PR, which has to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease

  • time to response [ Time Frame: Every 8 weeks after randomization ] [ Designated as safety issue: No ]
    time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently).

  • clinical benefit rate [ Time Frame: Every 8 weeks after randomization ] [ Designated as safety issue: No ]
    Proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in RECIST 1.1.

  • Type, frequency and severity of adverse events [ Time Frame: Continuous, until 30 days after treatment stops ] [ Designated as safety issue: Yes ]
    Safety will be determine by type, frequency and severity of adverse events per CTCAEv4.03 Type, frequency and severity of laboratory toxicities per CTCAEv4.03

  • Plasma concentration-time profiles of BKM120 - pharmacokinetics (PK) [ Time Frame: Cycle 1 day 1, 15, 16, 22 and Cycle 2 day 1. ] [ Designated as safety issue: No ]
    Summary statistics for PK: plasma concentration-time profiles of BKM120 and appropriate individual PK parameters based on population PK model , if deemed appropriate; each cycle = 28 days

  • Time to definitive deterioration of ECOG performance status [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    Time to definitive deterioration of the ECOG performance status from baseline


Estimated Enrollment: 524
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BKM120 and paclitaxel
BKM120 100 mg per day and paclitaxel 80 mg/m2 per week, given until progression or as described in the protocol.
Drug: BKM120
BKM120 daily oral capsules
Active Comparator: Placebo and paclitaxel
BKM120 matching placebo daily and paclitaxel 80 mg/m2 per week, given until progression or as described in the protocol.
Drug: Paclitaxel
intravenous paclitaxel 80 mg/m2 per week.
Other Name: Taxol
Drug: BKM120 matching placebo
BKM120 matching placebo, daily oral capsules

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer that is locally advanced or metastatic
  • HER2 negative disease, and a known hormone receptor status (common breast cancer classification tests)
  • A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
  • Adequate bone marrow and organ function
  • Measurable or non-measurable disease

Exclusion Criteria:

  • Prior chemotherapy for locally advanced or metastatic disease
  • Previous treatment with PI3K or AKT inhibitors
  • Symptomatic brain metastases
  • Concurrent malignancy or malignancy within 3 years prior to start of study treatment
  • Certain drugs or radiation within 2-4 weeks of enrollment
  • Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
  • Active heart (cardiac) disease as defined in the protocol
  • Known hypersensitivity or contraindications to use paclitaxel
  • Pregnant or nursing (lactating) woman
  • Certain scores on an anxiety and depression mood questionaire given at screening
  • Other protocol defined criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572727

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 154 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01572727     History of Changes
Other Study ID Numbers: CBKM120F2202, 2011-005932-24
Study First Received: April 4, 2012
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Hong Kong: Department of Health
Brazil: ENVISA
Italy: National Institute of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Korea: Korea Food and Drug Administration (KFDA)
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Taiwan : Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Israel: Ministry of Health
South Africa: Medicine Regulatory Authority (MRA)
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
BKM120
paclitaxel
breast cancer
metastatic
locally advanced
PI3K
PIK3CA
PTEN

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014