BKM120 For Triple Negative Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Nancy Lin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01790932
First received: February 7, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved BKM120 for use in patients, including people with your type of cancer.

BKM120 is a drug that works by blocking a protein called PI3K which may contribute to cancer growth. This drug has been used in experiments in the laboratory and information from these research studies suggests that BKM120 may help to prevent cancer cells from growing.

In this research study, the investigators are looking to see if BKM120 works to stop breast cancer cells from growing.


Condition Intervention Phase
Breast Cancer
Drug: BKM120
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of BKM120 in Patients With Triple Negative Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Rate of Clinical Benefit of BKM120 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the Progression Free Survival

  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Overall survival is defined as time from date of enrollment until death from any cause.


Estimated Enrollment: 110
Study Start Date: February 2013
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BKM120 Treatment Arm
100 mg capsule for oral use, taken once daily
Drug: BKM120

Detailed Description:

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 surgery.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically and radiologically confirmed metastatic triple negative breast cancer
  • At least two prior chemotherapy regimens in the neoadjuvant, adjuvant or metastatic setting
  • 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 acceptable)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790932

Contacts
Contact: Nancy Lin, MD 6176322335 nlin@partners.org

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nancy Lin, MD    617-632-2335    nlin@partners.org   
Principal Investigator: Nancy Lin, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nancy Lin, MD    617-632-2335    nlin@partners.org   
Principal Investigator: Nancy Lin, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Gerburg Wulf, MD    617-667-1910    gwulf@bidmc.harvard.edu   
Principal Investigator: Gerburg Wulf, MD, PhD         
Dana-Farber Cancer Institute at Faulkner Hospital Completed
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Nancy Lin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Nancy Lin, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01790932     History of Changes
Other Study ID Numbers: 12-438
Study First Received: February 7, 2013
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Metastatic
Triple Negative

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2014