Breast NeoplasmsPhase 2NCT00431067
Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy
A Phase 2 study testing BIBW 2992 in people with Breast Neoplasms, run by Boehringer Ingelheim at 12 sites in 2 countries.
Trial summary
The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 41 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Sep 2006to Aug 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+).
- Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.
- Age 18 years or older.
- Life expectancy of at least four (4) months.
- Written informed consent that is consistent with ICH-GCP guidelines.
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2.
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- Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should not have received treatment with hormone therapy within the last 2 weeks.
- Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1.
- Patients must have recovered from previous surgery.
- Patients must have measurable disease as defined by RECIST criteria.
Who cannot join
- Active infectious disease.
- Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
- Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal MRI scan at screening and be at least three months post-radiation or surgery.
- Cardiac left ventricular function with resting ejection fraction <50%.
- Absolute neutrophil count (ANC) less than 1500 cells/mm3.
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- Platelet count less than 100 000 cells/mm3.
- Bilirubin greater than 1.5 mg/dl (>26 micromol /L, SI unit equivalent).
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.
- Serum creatinine greater than 1.5 mg/dl (>132 micromol/L, SI unit equivalent).
- Women and men (and their partners) who are sexually active and unwilling to use a medically acceptable method of contraception.
- Pregnancy or breast-feeding.
- Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.
- Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).
- Patients unable to comply with the protocol.
- Active alcohol or drug abuse.
- Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States6 sites
1200.11.1 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1200.11.5 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina
1200.11.7 Boehringer Ingelheim Investigational Site
Encinitas, California
1200.11.4 Boehringer Ingelheim Investigational Site
Santa Monica, California
1200.11.3 Boehringer Ingelheim Investigational Site
Scottsdale, Arizona
1200.11.2 Boehringer Ingelheim Investigational Site
Tampa, Florida
United Kingdom6 sites
1200.11.4401 Boehringer Ingelheim Investigational Site
Bournemouth
1200.11.4402 Boehringer Ingelheim Investigational Site
Crownhill, Plymouth
1200.11.4406 Boehringer Ingelheim Investigational Site
Guildford
1200.11.4405 Boehringer Ingelheim Investigational Site
London
1200.11.4404 Boehringer Ingelheim Investigational Site
Poole
1200.11.4403 Boehringer Ingelheim Investigational Site
Truro
About this study
The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.
- 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
Also called BIBW 2992 (Afatinib) once daily until progression
| Study group | Role | What they receive |
|---|---|---|
| BIBW 2992 | Experimental | BIBW 2992 (Afatinib) once daily until progression Receives: Drug: BIBW 2992 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response (OR)
Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .
Measured: From first dose of study medication to response measurement, up to 34 month
Secondary outcomes (4)
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 criteria.
Measured: From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month
Overall Survival (OS)
OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.
Measured: From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month
Time to RECIST Tumour Reponse
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 criteria.
Measured: From first dose of study medication to time when OR measurement was taken.
Duration of Confirmed OR
Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).
Measured: From first OR to time of progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startSep 2006
- Primary completionAug 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
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT00431067
- Sponsor's protocol ID
- 1200.11
- Other IDs
- 2007-004805-80
- Status last verified
- Nov 2013
- First submitted
- 2 Feb 2007
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy
- ClinicalTrials.gov ID
- NCT00431067
- Acronym / sponsor ID
- 1200.11
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Aug 2009 (actual)
- First posted
- 5 Feb 2007 (estimated)
- Results
- Posted 23 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBW 2992 | Experimental | Drug: BIBW 2992BIBW 2992 (Afatinib) once daily until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+).
- Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.
- Age 18 years or older.
- Life expectancy of at least four (4) months.
- Written informed consent that is consistent with ICH-GCP guidelines.
Key exclusion criteria (17 listed)
- Active infectious disease.
- Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
- Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
- Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal MRI scan at screening and be at least three months post-radiation or surgery.
- Cardiac left ventricular function with resting ejection fraction <50%.
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 2992Also: BIBW 2992 (Afatinib) once daily until progression | Drug | BIBW 2992 |
Primary outcome
Objective Response (OR)
Time frame: From first dose of study medication to response measurement, up to 34 month
Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month
Overall Survival (OS)
Time frame: From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month
Time to RECIST Tumour Reponse
Time frame: From first dose of study medication to time when OR measurement was taken.
Duration of Confirmed OR
Time frame: From first OR to time of progression or death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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
12 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 12 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 10 inclusion and 17 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom. 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 Dec 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: From first dose of study medication to response measurement, up to 34 month). 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 9 Jun 2014.