Clinical trial of BKM120 in combination with tamoxifen in patients with breast cancer (hormone receptor-positive, HER2-negative, inoperable, locally advanced or metastatic)

Molecularly stratified parallel group phase II trial of the phosphoinositide 3-kinase (PI3K) inhibitor BKM120 in combination with tamoxifen in patients with hormone receptor-positive, HER2-negative inoperable (locally advanced or metastatic) breast cancer with prior exposure to antihormonal therapy - PIKTAM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000599-24-DE

Enrollment

330

Registered

2014-09-02

Start date

2014-12-18

Completion date

Unknown

Last updated

2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study population includes patients with histologically, progressive, inoperable (locally advanced or metastatic) hormone receptor (HR)–positive, HER2-negative breast cancer MedDRA version: 19.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms ben

Interventions

Product Name: Buparlisib Product Code: BKM120 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Buparlisib CAS Number: 944396-07-0 Current Sponsor code: BKM120 Other descriptive name: BUPARLISIB

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patient has histologically and/or cytologically confirmed diagnosis of breast cancer -Patient has radiologic or objective evidence of inoperable locally advanced, or metastatic breast cancer -Patient has a known hormone receptor status HR–positive (ER and/or PR positive) and HER2-negative status -Patient has a representative archival formalin-fixed tumor biopsy (metastasis or primary tumor) -Patient has prior exposure to antihormonal therapy -Patient has received = 2 prior antihormonal treatments in the metastatic setting -Prior treatment with tamoxifen in the (neo-)adjuvant setting is allowed but has to be discontinued for at least 1 year. -Patient may have received up to one prior chemotherapy in the metastatic setting -Measurable or non-measurable lesions according to RECIST v1.1 criteria -Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score = 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 165 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 165

Exclusion criteria

Exclusion criteria: -Patient has received previous treatment with a PI3K- or AKT-inhibitor or mTOR-inhibitors -Prior treatment with Tamoxifen in the metastatic setting. Treatment with tamoxifen in the (neo-)adjuvant setting is allowed, but has to be discontinued for at least 1 year -Patient has symptomatic CNS metastases -Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to DSM-IV). -Patient has a known history of HIV infection (testing not mandatory) infection

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate efficacy of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer stratified to PIK3CA mutation and preserved PTEN expression, loss of PTEN expression +/- PIK3CA mutation or PIK3CA wild type and preserved PTEN expression ;Secondary Objective: -To assess 6 month progression-free survival (PFS) rate. -To assess progression-free survival (PFS) -To explore overall survival (OS) -To assess overall response rate (ORR) -To assess disease control rate (DCR) -To assess safety and tolerability throughout the study according to CTCAE v4.03 -To assess incidence and severity of depressive episodes during the course of treatment;Primary end point(s): Progression free survival (PFS)-rate in the full population, after 6 months of combination therapy, defined by local investigator assessment;Timepoint(s) of evaluation of this end point: after 6 months	—

Measure

Time frame

Main Objective: To evaluate efficacy of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer stratified to PIK3CA mutation and preserved PTEN expression, loss of PTEN expression +/- PIK3CA mutation or PIK3CA wild type and preserved PTEN expression ;Secondary Objective: -To assess 6 month progression-free survival (PFS) rate. -To assess progression-free survival (PFS) -To explore overall survival (OS) -To assess overall response rate (ORR) -To assess disease control rate (DCR) -To assess safety and tolerability throughout the study according to CTCAE v4.03 -To assess incidence and severity of depressive episodes during the course of treatment;Primary end point(s): Progression free survival (PFS)-rate in the full population, after 6 months of combination therapy, defined by local investigator assessment;Timepoint(s) of evaluation of this end point: after 6 months

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Secondary

Measure	Time frame
Secondary end point(s): -Progression free survival (PFS)- rate in the subpopulations after 6 months of combination therapy -PFS in subpopulations and full population. PFS is defined as time from date of start of treatment to the date of the event, defined as the first documented disease progression or death due to any cause per local investigator assessment -OS in subpopulations and full population. OS is defined as time from date of start of treatment to the date of death from any cause. - ORR in subpopulations and full population. ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) - DCR in subpopulations and full population. DCR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 12 weeks -Type, frequency and severity of adverse events per CTCAE v4.03 -Change in depressive episodes assessed by PHQ-9 questionnaire and GAD-7;Timepoint(s) of evaluation of this end point: after 6 months or end of study	—

Measure

Time frame

Secondary end point(s): -Progression free survival (PFS)- rate in the subpopulations after 6 months of combination therapy -PFS in subpopulations and full population. PFS is defined as time from date of start of treatment to the date of the event, defined as the first documented disease progression or death due to any cause per local investigator assessment -OS in subpopulations and full population. OS is defined as time from date of start of treatment to the date of death from any cause. - ORR in subpopulations and full population. ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) - DCR in subpopulations and full population. DCR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 12 weeks -Type, frequency and severity of adverse events per CTCAE v4.03 -Change in depressive episodes assessed by PHQ-9 questionnaire and GAD-7;Timepoint(s) of evaluation of this end point: after 6 months or end of study

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Countries

Germany

Contacts

Public ContactContract Research Organization

iOMEDICO AG

info@iomedico.com+49761152420

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026