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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT01572727

Run by

Novartis Pharmaceuticals

People needed

416

Starts

2012-08-01

Expected to finish

2015-06-01

Last updated by the study team

2017-03-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Breast cancer that is locally advanced or metastatic
• HER2 negative disease, and a known hormone receptor status - ER/PgR (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

You may not qualify if…

• Prior chemotherapy for locally advanced or metastatic disease
• Previous treatment with PI3K or AKT inhibitors
• Patient has symptomatic CNS metastases
• Concurrent malignancy or malignancy within 3 years of study enrollment
• Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug
• 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

Where it is running

• Arizona Oncology Associates Dept of Oncology — Phoenix, Arizona, United States
• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States
• California Cancer Care Marian Speciality — Greenbrae, California, United States
• Rocky Mountain Cancer Centers RMCC Hale Pkwy — Greenwood Village, Colorado, United States
• H. Lee Moffitt Cancer Center & Research Institute SC — Tampa, Florida, United States
• Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2) — Atlanta, Georgia, United States
• Northwest Georgia Oncology Center NW Georgia Onc — Marietta, Georgia, United States
• University of Kansas Cancer Center Univ Kansas 2 — Kansas City, Kansas, United States
• Norton Healthcare, Inc. — Louisville, Kentucky, United States
• Washington University School of Medicine Regulatory — St Louis, Missouri, United States
• University of Nebraska Medical Center Unv Nebraska Med Ctr (2) — Omaha, Nebraska, United States
• University of New Mexico Cancer Research Center Dept of Univ New Mexico — Albuquerque, New Mexico, United States
• New York Oncology Hematology, P.C. Dept. of New York Oncology. PC — Troy, New York, United States
• Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1 — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center OUHSC 2 — Oklahoma City, Oklahoma, United States
• Northwest Cancer Specialists Vancouver Loc — Portland, Oregon, United States
• Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology — Dallas, Texas, United States
• University of Texas Southwestern Medical Center Harry Hines — Dallas, Texas, United States
• Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio — San Antonio, Texas, United States
• Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA — Reston, Virginia, United States
• Novartis Investigative Site — Sydney, New South Wales, Australia
• Novartis Investigative Site — Geelong, Victoria, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Nedlands, Western Australia, Australia
• Ironwood Cancer and Research Centers SC — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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