A Phase II Trial of BKM120 in Patients With Triple Negative Metastatic Breast Cancer
If you agree to participate in this research study you will be asked to undergo some tests
and procedures to confirm your eligibility. Many of these tests and procedures are likely to
be part of regular cancer care and may be done even if it turns out that you do not take
part in the research study. If you have had some of these tests and procedures recently,
they may or may not have to be repeated. These tests and procedures include: a medical
history, physical examination, vital signs, self-rated mood questionnaire, assessment of
your tumor, blood tests, serum pregnancy test, urine test and electrocardiogram. If these
tests show that you are eligible to participate in the research study, you will begin the
study treatment. If you do not meet the eligibility criteria, you will not be able to
participate in this research study.
The following additional research procedures will be performed at the time of study
screening: research blood sample and tumor tissue collection from a previous biopsy or
If you take part in this research study, you will be given a study drug-dosing calendar for
each treatment cycle. Each treatment cycle lasts 28 days during which time you will be
taking the study drug BKM120 once per day. You should take your BKM120 every day in teh
morning at approximately the same time. You will be required to keep a drug diary while on
this study. Please bring the drug diary with you to every clinic visit.
During Cycle 1 and Cycle 2, you will come into clinic every two weeks to undergo several
tests in order to evaluate your health status and to see how you are tolerating treatment,
as well as to evaluate any symptoms you may have. For all cycles thereafter, you will come
into clinic once a month every 4 weeks. Evaluations of your blood samples and physical
assessment may lead to changes in your study treatment.
On Day 1 of every Cycle and Day 15 of Cycle 1 and 2 you will undergo the following: vital
signs, physical examination, blood tests, two self-rated mood questionnaires, uring test,
scans (or imaging tests), tumor biopsies.
You will return for an end of treatment visit approximately 7 days after stopping your study
medication. At this visit the following assessments will be performed: vital signs, physical
examination, blood tests, research blood sample, urine test, two self-rated mood
questionnaires, electrocardiogram and tumor biopsy.
If you stopped the study medication for other reasons than your condition worsening, a
member of the research study staff will contact you or your physician every 3 months for a
total of 2 years after the discontinuation of the study treatment, in order to obtain more
information on which additional therapy you have received for your disease, or how your
disease is evolving. If you do not terminate study treatment early you will be in this
research study for about 3 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of Clinical Benefit of BKM120
Rate of Clinical Benefit is calculated as equal to the Sum of the Complete Response (CR) plus Partial Response (PR) plus Stable Disease (SD) for greater than or equal to 4 months per the RECIST 1.1 criteria.
Nancy Lin, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Dana-Farber Cancer Institute at Faulkner Hospital||Boston, Massachusetts 02215|