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A Randomized, Double-blind, Placebo Controlled, Phase II Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Randomized, Double-blind, Placebo Controlled, Phase II Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

progression free survival (PFS)

Outcome Description:

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

Outcome Time Frame:

Every 8 weeks after randomization

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

November 2014

Related Keywords:

  • Breast Cancer
  • BKM120
  • paclitaxel
  • breast cancer
  • metastatic
  • locally advanced
  • PI3K
  • PIK3CA
  • PTEN
  • Breast Neoplasms



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Ironwood Cancer and Research Centers IronwoodChandler, Arizona  85224
Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
University of Nebraska Medical Center Unv Nebraska Med Ctr (2)Omaha, Nebraska  68198
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Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)Atlanta, Georgia  30322
Washington University School Of Medicine-Siteman Cancer Ctr Was Univ School of MedSt. Louis, Missouri  63110
Loma Linda University Dept.ofLomaLindaCancerCent(3)Loma Linda, California  
University of Colorado Univ CO Cancer CtrAurora, Colorado  80045
H. Lee Moffitt Cancer Center/University of South Florida SCTampa, Florida  33612
University of Kansas Cancer Center Univ Kansas 2Kansas City, Kansas  66160
University of Oklahoma Health Sciences Center OUHSC 2Oklahoma City, Oklahoma  73104
Northwest Cancer Specialists Vancouver LocPortland, Oregon  97210
University of Texas Southwestern Medical Center Harry HinesDallas, Texas  75390-8527
Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VAReston, Virginia  20190
Texas Oncology, P.A. Central Austin CancerCenter(2)Dallas, Texas  75251
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Northwest Georgia Oncology Center NW Georgia OncMarietta, Georgia  30060
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Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1Columbus, Ohio  43210