OHSU

IRB #

IRB00009076

Title

A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatment

Principal Investigator

Robert Raish

Study Purpose

To find out if BKM120 plus fulvestrant prolongs survival compared to placebo plus fulvestrant

Medical Condition(s)

Breast cancer

Eligibility Criteria

1. Evidence of locally advanced or metastatic disease.
2. HER2- and HR+ breast cancer
3. Previously treated with aromatase inhibitors (AIs)
4. Evidence of progressive disease after mTOR and endocrine therapy
5. Other criteria may apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Until disease progression, unacceptable side effects, death, or discontinuation for any other reasons.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Novartis

Recruitment End

12/31/2014

Compensation Provided

No


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