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
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
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:
Interventional
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:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CBKM120F2202
NCT ID:
NCT01572727
Start Date:
August 2012
Completion Date:
November 2014
Related Keywords:
- Breast Cancer
- BKM120
- paclitaxel
- breast cancer
- metastatic
- locally advanced
- PI3K
- PIK3CA
- PTEN
- Breast Neoplasms
Name | Location |
|---|---|
| Norton Healthcare, Inc. | Louisville, Kentucky 40202 |
| California Cancer Care Marian Speciality | Greenbrae, California 94904 |
| US Oncology Central Monitoring | Dallas, Texas 75246 |
| Ironwood Cancer and Research Centers Ironwood | Chandler, Arizona 85224 |
| Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville, Arkansas 72703 |
| University of Nebraska Medical Center Unv Nebraska Med Ctr (2) | Omaha, Nebraska 68198 |
| New York Oncology Hematology, P.C. Dept. of New York Oncology. PC | Troy, New York 12180 |
| 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 Med | St. Louis, Missouri 63110 |
| Loma Linda University Dept.ofLomaLindaCancerCent(3) | Loma Linda, California |
| University of Colorado Univ CO Cancer Ctr | Aurora, Colorado 80045 |
| H. Lee Moffitt Cancer Center/University of South Florida SC | Tampa, Florida 33612 |
| University of Kansas Cancer Center Univ Kansas 2 | Kansas City, Kansas 66160 |
| University of Oklahoma Health Sciences Center OUHSC 2 | Oklahoma City, Oklahoma 73104 |
| Northwest Cancer Specialists Vancouver Loc | Portland, Oregon 97210 |
| University of Texas Southwestern Medical Center Harry Hines | Dallas, Texas 75390-8527 |
| Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA | Reston, Virginia 20190 |
| Texas Oncology, P.A. Central Austin CancerCenter(2) | Dallas, Texas 75251 |
| Baylor College of Medicine Baylor Texas Oncology | Dallas, Texas 75246 |
| Southern Cancer Center PC | Mobile, Alabama 36608 |
| Arizona Oncology Associates Dept of Oncology | Phoenix, Arizona |
| Rocky Mountain Cancer Centers RMCC Hale Pkwy | Greenwood Village, Colorado |
| Northwest Georgia Oncology Center NW Georgia Onc | Marietta, Georgia 30060 |
| University of New Mexico Cancer Research Center Dept of Univ New Mexico | Albuquerque, New Mexico 87131 |
| Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1 | Columbus, Ohio 43210 |
