Breast NeoplasmsPhase 2NCT00425854
An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
A Phase 2 study testing BIBW 2992 in people with Breast Neoplasms, run by Boehringer Ingelheim at 14 sites in 2 countries.
Trial summary
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- BIBW 2992
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Nov 2006to May 2009
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients age 18 years or older
- Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
- HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
- At least one measurable tumour lesion (RECIST);
- Availability of tumour samples
- Written informed consent that is consistent with ICH-GCP guidelines and local law
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.
Who cannot join
- Active infectious disease
- Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
- Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
- Active/symptomatic brain metastases
- Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
- ANC less than 1500/mm3 platelet count less than 100 000/mm3
Show all 15Show fewer
- Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)
- AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
- Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breast-feeding
- Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
- Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
- Active alcohol or drug abuse
- Other malignancy within the past 5 years
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Germany8 sites
1200.10.49005 Boehringer Ingelheim Investigational Site
Berlin
1200.10.49007 Boehringer Ingelheim Investigational Site
Düsseldorf
1200.10.49008 Boehringer Ingelheim Investigational Site
Erlangen
1200.10.49010 Boehringer Ingelheim Investigational Site
Essen
1200.10.49003 Boehringer Ingelheim Investigational Site
Kiel
1200.10.49004 Boehringer Ingelheim Investigational Site
Mainz
1200.10.49001 Boehringer Ingelheim Investigational Site
München
1200.10.49006 Boehringer Ingelheim Investigational Site
Wiesbaden
Belgium6 sites
1200.10.3201 Boehringer Ingelheim Investigational Site
Brussels
1200.10.3208 Boehringer Ingelheim Investigational Site
Brussels
1200.10.3203 Boehringer Ingelheim Investigational Site
Charleroi
1200.10.3205 Boehringer Ingelheim Investigational Site
Ghent
1200.10.3204 Boehringer Ingelheim Investigational Site
Leuven
1200.10.3206 Boehringer Ingelheim Investigational Site
Wilrijk
About this study
Official title: An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.
- Conditions
- Breast Neoplasms
- Being tested
- BIBW 2992
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBW 2992Drug
high dose once daily
| Study group | Role | What they receive |
|---|---|---|
| BIBW 2992 | Experimental | high dose once daily Receives: Drug: BIBW 2992 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response (OR)
OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Clinical Benefit (CB)
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Secondary outcomes (8)
Clinical Benefit (CB)
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Time to OR
The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of OR
Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Progression-free Survival (PFS)
PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Overall Survival (OS)
OS is defined as time from randomisation to death.
Measured: From randomisation to end of follow-up.
Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)
LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.
Measured: Baseline and last assessment
Best Change From Baseline in ECOG Performance Status
Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).
Measured: baseline till end of treatment
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)
Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
Measured: day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425854
- Sponsor's protocol ID
- 1200.10
- Other IDs
- 2006-002018-36
- Status last verified
- Aug 2013
- First submitted
- 22 Jan 2007
- Last updated
- 31 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT00425854
- Acronym / sponsor ID
- 1200.10
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- May 2009 (actual)
- First posted
- 23 Jan 2007 (estimated)
- Results
- Posted 14 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBW 2992 | Experimental | Drug: BIBW 2992high dose once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients age 18 years or older
- Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
- HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
- At least one measurable tumour lesion (RECIST);
- Availability of tumour samples
Key exclusion criteria (15 listed)
- Active infectious disease
- Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
- Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
- Active/symptomatic brain metastases
- Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
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 |
|---|---|---|
| BIBW 2992high dose once daily | Drug | BIBW 2992 |
Primary outcome
Objective Response (OR)
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.
Clinical Benefit (CB)
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.
8 secondary outcomes
Clinical Benefit (CB)
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Time to OR
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of OR
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Progression-free Survival (PFS)
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Overall Survival (OS)
Time frame: From randomisation to end of follow-up.
Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and last assessment
Best Change From Baseline in ECOG Performance Status
Time frame: baseline till end of treatment
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)
Time frame: day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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)
TNBC - Triple-Negative Breast Cancer
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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBW 2992 in people with Breast Neoplasms, run by Boehringer Ingelheim at 14 sites in 2 countries.
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 7 inclusion and 15 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 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Belgium. 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 14 Oct 2013). 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?
Objective Response (OR) (time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2013.