Breast CancerPhase 2PIKTAMNCT02404844

Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer

A Phase 2 study testing BKM120 and Tamoxifen in people with Breast Cancer, run by University Hospital, Essen at 1 site in Germany.

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

This is a clinical trial with a molecularly stratified parallel cohort, single arm design to explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer with prior exposure to antihormonal therapy, and different biomarker profiles, two of them… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: BKM120 and Tamoxifen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteGermany
Study dates: Dec 2014to 19 Oct 2017
Phase: Phase 2
Are there results?: None posted in the registry

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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

iOMEDICO AG
Freiburg im Breisgau, Baden-Wurttemberg, 79108

Other trials in Germany

About this study

Official title: Molecularly Stratified Parallel Cohort, Single Arm Phase II Trial of the Phosphoinositide 3-kinase (PI3K) Inhibitor Buparlisib (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

Read the detailed description

PIK3CA mutation/preserved PTEN expression
PIK3CA wildtype or mutation/ loss of PTEN expression
PIK3CA wildtype/preserved PTEN expression. This trial will explore, if the combination of BKM120 and tamoxifen can overcome resistance to antihormonal therapies. BKM120 is selective for class I PI3K enzymes with no mTOR inhibitory activity that has entered Phase II and III clinical trials. The tumor suppressor PTEN is the most important negative regulator of the PI3K signaling pathway. Therefore, in addition the trial will prospectively evaluate PIK3CA mutations and/or loss of PTEN expression as predictive biomarkers for clinical benefit from combined treatment with BKM120 and tamoxifen.

Conditions: Breast Cancer
Being tested: BKM120, Tamoxifen
Medical subject headings: Breast Neoplasms

What participants receive

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

BKM120Drug
Also called Buparlisib
daily oral
TamoxifenDrug
daily oral

Study groups in NCT02404844
Study group	Role	What they receive
BKM120 + Tamoxifen	Experimental	BKM120 (Buparlisib): 100 mg/day, orally, on a continuous dosing schedule without interruption starting on day 1 in 28 day cycle Tamoxifen: 20 mg/day, orally, on a continuous dosing schedule without interruption starting on day 1 in 28 day cycle Receives: Drug: BKM120; Drug: Tamoxifen

What is being measured

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

Progression free survival (PFS)-rate in the full population, after 6 months
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
Measured: 6 months

Secondary outcomes (9)

Progression free survival (PFS)- rate in the subpopulations after 6 months of combination therapy
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
Measured: 6 months
Progression-free survival (PFS)
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
Measured: 6 months
1 year overall survival (OS) rate
OS is defined as time from date of start of treatment to the date of death from any cause.
Measured: 1 year
2 years overall survival (OS) rate
OS is defined as time from date of start of treatment to the date of death from any cause.
Measured: 2 years
Overall response rate (ORR)
ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) (RECIST v1.1).
Measured: 6 months
Disease control rate (DCR)
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 (RECIST v1.1).
Measured: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Type, frequency and severity of adverse events per CTCAE v4.03
Measured: From date of informed consent to +30 days from last application of study medication
Incidence and severity of depressive episodes during the course of treatment
Change in depressive episodes assessed by PHQ-9 questionnaire
Measured: From date of informed consent to +30 days from last application of study medication
Incidence and severity of depressive episodes during the course of treatment
Change in depressive episodes assessed by GAD-7 questionnaire
Measured: From date of informed consent to +30 days from last application of study medication

Timeline

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

Dec 201419 Oct 2017

First posted1 Apr 2015 (estimated)
Study startDec 2014
Primary completion19 Sep 2017
Study completion19 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02404844
Sponsor's protocol ID: iOM-02282
Other IDs: 2014-000599-24, CBKM120ZDE02T, AIO-MAM-0114/ass, 2014
Acronym: PIKTAM
Status last verified: Apr 2018
First submitted: 20 Feb 2015
Last updated: 20 Apr 2018
Results posted: No
Data monitoring committee: No

Publications

Bendell JC, Rodon J, Burris HA, de Jonge M, Verweij J, Birle D, Demanse D, De Buck SS, Ru QC, Peters M, Goldbrunner M, Baselga J. Phase I, dose-escalation study of BKM120, an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2012 Jan 20;30(3):282-90. doi: 10.1200/JCO.2011.36.1360. Epub 2011 Dec 12.
PubMed 22162589
Rodon J, Brana I, Siu LL, De Jonge MJ, Homji N, Mills D, Di Tomaso E, Sarr C, Trandafir L, Massacesi C, Eskens F, Bendell JC. Phase I dose-escalation and -expansion study of buparlisib (BKM120), an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2014 Aug;32(4):670-81. doi: 10.1007/s10637-014-0082-9. Epub 2014 Mar 21.
PubMed 24652201

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Molecularly Stratified Parallel Cohort, Single Arm Phase II Trial of the Phosphoinositide 3-kinase (PI3K) Inhibitor Buparlisib (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
ClinicalTrials.gov ID: NCT02404844
Acronym / sponsor ID: PIKTAM / iOM-02282
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: University Hospital, EssenUniversity, hospital or other
Collaborators: iOMEDICO AG, Novartis Pharmaceuticals
Study start: Dec 2014
Primary completion: 19 Sep 2017 (actual)
Study completion: 19 Oct 2017 (actual)
First posted: 1 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PIK3CA mutation/preserved PTEN expression
PIK3CA wildtype or mutation/ loss of PTEN expression
PIK3CA wildtype/preserved PTEN expression. This trial will explore, if the combination of BKM120 and tamoxifen can overcome resistance to antihormonal therapies. BKM120 is selective for class I PI3K enzymes with no mTOR inhibitory activity that has entered Phase II and III clinical trials. The tumor suppressor PTEN is the most important negative regulator of the PI3K signaling pathway. Therefore, in addition the trial will prospectively evaluate PIK3CA mutations and/or loss of PTEN expression as predictive biomarkers for clinical benefit from combined treatment with BKM120 and tamoxifen.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BKM120 + Tamoxifen	Experimental	Drug: BKM120, Drug: TamoxifenBKM120 (Buparlisib): 100 mg/day, orally, on a continuous dosing schedule without interruption starting on day 1 in 28 day cycle Tamoxifen: 20 mg/day, orally, on a continuous dosing schedule without interruption starting on day 1 in 28 day cycle

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BKM120Also: Buparlisibdaily oral	Drug	BKM120 + Tamoxifen
Tamoxifendaily oral	Drug	BKM120 + Tamoxifen

Primary outcome

Progression free survival (PFS)-rate in the full population, after 6 months
Time frame: 6 months
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

9 secondary outcomes

Progression free survival (PFS)- rate in the subpopulations after 6 months of combination therapy
Time frame: 6 months
Progression-free survival (PFS)
Time frame: 6 months
1 year overall survival (OS) rate
Time frame: 1 year
2 years overall survival (OS) rate
Time frame: 2 years
Overall response rate (ORR)
Time frame: 6 months
Disease control rate (DCR)
Time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: From date of informed consent to +30 days from last application of study medication
Incidence and severity of depressive episodes during the course of treatment
Time frame: From date of informed consent to +30 days from last application of study medication
Incidence and severity of depressive episodes during the course of treatment
Time frame: From date of informed consent to +30 days from last application of study medication

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
Background: PubMed 22162589Bendell JC, Rodon J, Burris HA, de Jonge M, Verweij J, Birle D, Demanse D, De Buck SS, Ru QC, Peters M, Goldbrunner M, Baselga J. Phase I, dose-escalation study of BKM120, an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2012 Jan 20;30(3):282-90. doi: 10.1200/JCO.2011.36.1360. Epub 2011 Dec 12.
Background: PubMed 24652201Rodon J, Brana I, Siu LL, De Jonge MJ, Homji N, Mills D, Di Tomaso E, Sarr C, Trandafir L, Massacesi C, Eskens F, Bendell JC. Phase I dose-escalation and -expansion study of buparlisib (BKM120), an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2014 Aug;32(4):670-81. doi: 10.1007/s10637-014-0082-9. Epub 2014 Mar 21.

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Active, not recruiting
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RecruitingPhase 2
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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
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RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anja Welt, MD principal investigator

University Hospital, Essen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BKM120 and Tamoxifen in people with Breast Cancer, run by University Hospital, Essen at 1 site in Germany.

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 10 inclusion and 5 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 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression free survival (PFS)-rate in the full population, after 6 months (time frame: 6 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 NCT02404844, which also lists 2 linked publications.

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 20 Apr 2018.