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Breast CancerPhase 2NCT01790932

BKM120 For Triple Negative Breast Cancer

A Phase 2 study testing BKM120 in people with Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Triple negative breast cancer (TNBC) has an aggressive phenotype and poor prognosis. This tumor type characterized by lack of expression of estrogen receptor (ER), progesterone receptor (PR) and no amplification of the human epidermal growth factor 2 (HER2) accounts for 15% of breast cancers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
BKM120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesUnited States
Study dates
Jun 2012to Sep 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically and radiologically confirmed metastatic triple negative breast cancer
  • Up to two prior lines of chemotherapy for metastatic breast cancer
  • Availability of a representative tumor specimen
  • At least one measurable lesion

Who cannot join

  • Have received previous treatment with PI3K inhibitors
  • Symptomatic central nervous system (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 Common Toxicity Criteria for Adverse Events (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
Show all 18Show fewer
  • 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 Cytochrome P450, family 3, subfamily A (CYP3A)
  • Known history of human immunodeficiency virus (HIV)
  • Pregnant or breastfeeding
  • Unwilling to observe total abstinence or to use double barrier method for birth control throughout trial

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Dana-Farber Cancer Institute at Faulkner Hospital

    Boston, Massachusetts, 02130

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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

Triple negative breast cancer (TNBC) has an aggressive phenotype and poor prognosis. This tumor type characterized by lack of expression of estrogen receptor (ER), progesterone receptor (PR) and no amplification of the human epidermal growth factor 2 (HER2) accounts for 15% of breast cancers. Limited treatment options exist in the clinic as hormonal therapies and HER2-trageted agents have proven ineffective. BKM120 is a drug that works by blocking a protein called phosphatidylinositol-3-kinase (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.

Read the detailed description

Study plan Two investigator-initiated protocols (one for US, one for Spain) will be enrolling in parallel. The first 50 participants will be recruited concurrently in US and Spain.

Stage 1 Stage 1 will include up to 50 participants with advanced TN disease. Available tumor block is required in all participants per inclusion criteria. Analysis of this tumor block will be used for correlation of predictive markers and clinical response in order to define potential subpopulation that benefit from BKM120. In Stage 1, all participants will have biopsies done at baseline, cycle 1 day 28/cycle 2 day 1 and end of treatment to analyze drug effect in the PI3K and mitogen-activated protein kinases (MAPK) pathway. This will aid to understand the pharmacodynamic effects of BKM120 in tumors with similar genetic background (triple negative disease). The enrollment of Stage 1 will ensure that at least 10 paired evaluable biopsies are obtained. After the enrollment of the first 29 evaluable subjects enrolled overall in Stage 1 (considering the US and the Spanish protocol), the Steering Committee will perform an interim analysis of safety and efficacy. If absolutely no activity is observed, the clinical trial will close and no more subjects will be enrolled. If there are early signs of activity (one patient or more achieving clinical benefit response), enrollment will proceed until 50 participants are enrolled in Stage 1. After 50 patients have been enrolled, we will analyze preliminary responses to treatment depending on the molecular status of each patient.

Stage 2 Were the trial to continue at the end of Stage 1, 50 participants would have been treated and their clinical status and response to therapy will be available. Also, paraffin blocks from these participants will have been analyzed for predictive markers of treatment effect. If there is clinical activity observed in Stage 1 and this analysis shows preliminary signs of response in a subpopulation based on the presence or absence of tumor PI3K pathway alterations, participant pre-selection may be implemented for Stage 2 (justified in an amendment before proceeding to Stage 2.

Conditions
Breast Cancer
Being tested
BKM120
Keywords
Metastatic, Triple Negative
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BKM120Drug

    Also called Buparlisib

Study groups in NCT01790932
Study groupRoleWhat they receive
BKM120ExperimentalBKM120: 100 mg capsule once daily each day of a 28 day cycle . Treatment with BKM120 will continue until disease progression, unacceptable toxicity or withdrawal for other reasons.
Receives: Drug: BKM120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Benefit Rate

    Clinical benefit rate (CBR) was defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.

    Measured: Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months.

Secondary outcomes (2)

  1. Progression Free Survival

    Progression-free survival (PFS) based on the Kaplan-Meier (KM) method is defined as the duration of time from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at the date of last disease assessment. Per RECIST 1.1 criteria: PD is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

    Measured: Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for PFS on average approximately 2 months.

  2. Overall Survival

    Overall survival (OS) is defined as the duration of time from study entry to death or date last known alive and estimated using the KM method.

    Measured: Participants were assessed every 3 months post-treatment up to 2 years. Average survival follow-up for the study cohort was 13.8 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01790932
Sponsor's protocol ID
12-438
Status last verified
Jan 2019
First submitted
7 Feb 2013
Last updated
23 Jan 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Garrido-Castro AC, Saura C, Barroso-Sousa R, Guo H, Ciruelos E, Bermejo B, Gavila J, Serra V, Prat A, Pare L, Celiz P, Villagrasa P, Li Y, Savoie J, Xu Z, Arteaga CL, Krop IE, Solit DB, Mills GB, Cantley LC, Winer EP, Lin NU, Rodon J. Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer. Breast Cancer Res. 2020 Nov 2;22(1):120. doi: 10.1186/s13058-020-01354-y.

    PubMed 33138866

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BKM120 in people with Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Benefit Rate (time frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01790932, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.

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