Breast NeoplasmsPhase 2NCT01271725
LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures
A Phase 2 study testing Vinorelbine 25 mg/m2 weekly, Afatinib 40mg once daily (OD) and Paclitaxel 80 mg/m2 weekly in people with Breast Neoplasms, run by Boehringer Ingelheim at 27 sites in 6 countries.
Trial summary
The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who… 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?
- Vinorelbine 25 mg/m2 weekly, Afatinib 40mg once daily (OD) and Paclitaxel 80 mg/m2 weekly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 24 May 2011to 13 Mar 2017
- 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 >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- Stage IV metastatic disease
- At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target lesions
- Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting
Who cannot join
- Prior first line therapy for metastatic breast cancer
- Known pre-existing interstitial lung disease
- Active brain metastases
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to trial treatment.
- Cardiac left ventricular function with resting ejection fraction of less than 50%.
- Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting
- Prior treatment with paclitaxel in the past 12 months
- Must not have received prior vinorelbine treatment - Further exclusion criteria apply
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
Russia8 sites
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
Kazan', 420029
Clinical Oncology Dispensary No. 1, Dept. Chemotherapy
Krasnodar, 350040
N.A. Semashko Central Clinical Hospital, Moscow
Moscow, 129128
SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"
Pyatigorsk, 357502
SBIH "Samara Regional Clinical Oncol. Dispensary", Samara
Samara, 443 031
GUZ "Oncological Dispesary #2"
Sochi, 354057
Stavropol Regional Clin. Oncology Dispensary Dept. Oncology
Stavropol, 355 047
Yaroslavl Regional Clinical Oncology Hosp. Dept.Chemotherapy
Yaroslavl, 150 040
India6 sites
Sujan Surgical Cancer Hospital
Amravati, 444606
Tata Memorial Hospital
Maharashtra, 400 012
Curie Manavata Cancer Centre
Maharashtra, 422 004
Central India Cancer Research Institute
Nagpur, 440010
Ruby Hall Clinic
Pune, 411001
Regional Cancer Center
Thiruvananthapuram, 695 011
Taiwan6 sites
China Medical University Hospital
Taichung, 404
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital
Taipei, 10449
Koo Foundation Sun Yet-Sen Cancer Center
Taipei, 112
Taipe Veterans General Hospital
Taipei, 112
United Kingdom4 sites
North Devon District Hospital
Barnstaple, EX31 4JB
Royal Bournemouth and Christchurch Hospital
Bournemouth, BH7 7DW
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
Charing Cross Hospital
London, W6 8RF
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin
About this study
Official title: LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the Neoadjuvant and/or Adjuvant Treatment Setting
The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting
- Conditions
- Breast Neoplasms
- Being tested
- Vinorelbine 25 mg/m2 weekly, Afatinib 40mg once daily (OD), Paclitaxel 80 mg/m2 weekly
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinorelbine 25 mg/m2 weeklyDrug
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
Afatinib 40mg once daily (OD)Drug
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
Paclitaxel 80 mg/m2 weeklyDrug
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Afatinib 40mg once daily (OD) | Experimental | Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease Receives: Drug: Afatinib 40mg once daily (OD) |
| Paclitaxel 80 mg/m2 weekly | Experimental | Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy Receives: Drug: Paclitaxel 80 mg/m2 weekly |
| Vinorelbine 25 mg/m2 weekly | Experimental | Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy Receives: Drug: Vinorelbine 25 mg/m2 weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1
Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.
Measured: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Secondary outcomes (8)
Best Overall Response According to RECIST v1.1 (With Confirmation)
Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Measured: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation)
Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part (without clinical disease assessment) .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Measured: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Progression Free Survival (PFS)
Progression Free Survival is defined as the time from the drug start date to the date of 1st disease progression or death for monotherapy and 2nd disease progression or death from the drug start date of the combination therapy for combination therapy'. Median is calculated from the Kaplan-Meier curve.
Measured: From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression
Duration of Objective Response According to RECIST v1.1
Duration of objective response, defined as the time from first objective response to the time of progression or death. (regardless of confirmation). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Measured: From the first objective response to the time of progression or death, up to 1562 days
Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher
Percentage of patients with highest common terminology criteria for adverse events (CTCAE) version 3.0 Grade of 3 or higher.
Measured: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)
Change from baseline to end of treatment in systolic blood pressure (SBP).
Measured: Baseline and End of treatment period, up to 1562 days
Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)
Change from baseline to end of treatment in diastolic blood pressure (DBP).
Measured: Baseline and End of treatment period, up to 1562 days
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values
Number of patient with possibly clinically significant (PCS) laboratory values by functional group (haematology, differentials, coagulation, electrolytes, enzymes, and substrates). Acronyms Used: Prothrombin time-International normalized ratio (PT-INR), Alanine aminotransferase/Glutamic pyruvic transaminase (ALT/GPT) Serum glutamic pyruvic transaminase (SGPT), Aspartate aminotransferase/Glutamic-oxaloacetic transaminase (AST/GOT) Serum glutamic-oxaloacetic transaminase (SGOT)
Measured: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study start24 May 2011
- Primary completion13 Mar 2017
- Study completion13 Mar 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 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
- NCT01271725
- Sponsor's protocol ID
- 1200.98
- Other IDs
- 2010-021945-29
- Status last verified
- Mar 2019
- First submitted
- 6 Jan 2011
- Last updated
- 17 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Hickish T, Mehta A, Liu MC, Huang CS, Arora RS, Chang YC, Yang Y, Vladimirov V, Jain M, Tsang J, Pemberton K, Sadrolhefazi B, Jin X, Tseng LM. Afatinib alone and in combination with vinorelbine or paclitaxel, in patients with HER2-positive breast cancer who failed or progressed on prior trastuzumab and/or lapatinib (LUX-Breast 2): an open-label, multicenter, phase II trial. Breast Cancer Res Treat. 2022 Apr;192(3):593-602. doi: 10.1007/s10549-021-06449-4. Epub 2022 Feb 9.
PubMed 35138529
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the Neoadjuvant and/or Adjuvant Treatment Setting
- ClinicalTrials.gov ID
- NCT01271725
- Acronym / sponsor ID
- 1200.98
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 24 May 2011 (actual)
- Primary completion
- 13 Mar 2017 (actual)
- Study completion
- 13 Mar 2017 (actual)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Afatinib 40mg once daily (OD) | Experimental | Drug: Afatinib 40mg once daily (OD)Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease |
| Paclitaxel 80 mg/m2 weekly | Experimental | Drug: Paclitaxel 80 mg/m2 weeklyPatients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy |
| Vinorelbine 25 mg/m2 weekly | Experimental | Drug: Vinorelbine 25 mg/m2 weeklyPatients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- Stage IV metastatic disease
- At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target lesions
- Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting
Key exclusion criteria (8 listed)
- Prior first line therapy for metastatic breast cancer
- Known pre-existing interstitial lung disease
- Active brain metastases
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to trial treatment.
- Cardiac left ventricular function with resting ejection fraction of less than 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 |
|---|---|---|
| Vinorelbine 25 mg/m2 weeklyPatients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy | Drug | Vinorelbine 25 mg/m2 weekly |
| Afatinib 40mg once daily (OD)Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease | Drug | Afatinib 40mg once daily (OD) |
| Paclitaxel 80 mg/m2 weeklyPatients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy | Drug | Paclitaxel 80 mg/m2 weekly |
Primary outcome
Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1
Time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.
8 secondary outcomes
Best Overall Response According to RECIST v1.1 (With Confirmation)
Time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation)
Time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Progression Free Survival (PFS)
Time frame: From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression
Duration of Objective Response According to RECIST v1.1
Time frame: From the first objective response to the time of progression or death, up to 1562 days
Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher
Time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)
Time frame: Baseline and End of treatment period, up to 1562 days
Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)
Time frame: Baseline and End of treatment period, up to 1562 days
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values
Time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35138529Hickish T, Mehta A, Liu MC, Huang CS, Arora RS, Chang YC, Yang Y, Vladimirov V, Jain M, Tsang J, Pemberton K, Sadrolhefazi B, Jin X, Tseng LM. Afatinib alone and in combination with vinorelbine or paclitaxel, in patients with HER2-positive breast cancer who failed or progressed on prior trastuzumab and/or lapatinib (LUX-Breast 2): an open-label, multicenter, phase II trial. Breast Cancer Res Treat. 2022 Apr;192(3):593-602. doi: 10.1007/s10549-021-06449-4. Epub 2022 Feb 9.
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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
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine 25 mg/m2 weekly, Afatinib 40mg once daily (OD) and Paclitaxel 80 mg/m2 weekly in people with Breast Neoplasms, run by Boehringer Ingelheim at 27 sites in 6 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 4 inclusion and 8 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 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Russia, India, Taiwan, United Kingdom, Hong Kong and 1 more country. 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 17 Jun 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?
Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1 (time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days). 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 NCT01271725, 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 17 Jun 2019.