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A Phase II Trial of BKM120 in Patients With Triple Negative Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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.

Inclusion Criteria:

- Pathologically and radiologically confirmed metastatic triple negative breast cancer

- At least two prior chemotherapy regimens in the neoadjuvant, adjuvant or metastatic

- Availability of a representative tumor specimen

- At least one measurable lesion

Exclusion Criteria:

- Have received previous treatment with PI3K inhibitors

- Symptomatic CNS metastases (controlled and asymptomatic CNS metastases are

- Concurrent malignancy or has a malignancy within 3 years of study enrollment

- Any of the following mood disorders: active major depressive episode, bipolar
disorder, obsessive-compulsive disorder, schizophrenia, history of suicidal attempt
or ideation, homicidal ideation, greater than or equal to CTCAE grade 3 anxiety

- Concurrently using other approved or investigational antineoplastic agent and/or
chemotherapy within 21 days prior to enrollment in this study

- Has received radiation therapy within 28 days prior to enrollment in this study or
has not recovered from side effects of such therapy

- Major surgery within 28 days of starting therapy or has not recovered from major side
effects of a previous surgery

- Poorly controlled diabetes mellitus

- History of cardiac dysfunction

- Currently receiving treatment with QT prolonging medication and the treatment cannot
be discontinued or switched to a different medication

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of BKM120

- Receiving chronic treatment with steroids or another immunosuppressive agent

- Other concurrent severe and/or uncontrolled medical condition that would
contraindicate participation in this study

- History of non-compliance to a medical regimen

- Currently being treated with drugs known to be moderate or strong inhibitors or
inducers of isoenzyme CYP3A

- Known history of HIV

- Pregnant or breastfeeding

- Unwilling to observe total abstinence or to use double barrier method for birth
control throughout trial

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of Clinical Benefit of BKM120

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Nancy Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic
  • Triple Negative
  • Breast Neoplasms



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