Metastatic Breast CancerPhase 2NCT01161368
A Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients
A Phase 2 study testing Lapatinib, Vinorelbine in people with Metastatic Breast Cancer, run by Central European Cooperative Oncology Group at 2 sites in 2 countries.
Trial summary
The objective of this phase II study is to gain first information on the efficacy (PFS, ORR and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive metastatic breast cancer pretreated with a combination therapy (chemotherapy and/or hormonal therapy) including lapatinib and presenting with tumor… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Lapatinib, Vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2010to May 2014
- 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
- Written informed consent obtained prior to any study-specific procedure.
- Females ≥18 years.
- Histologically or cytologically confirmed, HER2-positive (HER+++ or HER++ and FISH positive), adenocarcinoma of the breast with measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent.
- Presence of at least one measurable lesion according to RECIST Criteria version 1.1. (target lesion(s) must not lie within an irradiated area)
- Able to comply with the protocol.
- Prior treatment with a combination therapy including lapatinib as first or second-line treatment for metastatic disease.
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- ECOG performance status of 0-1.
- Life expectancy more than 12 weeks.
- Adequate left ventricular ejection function at baseline, defined as LVEF ≥ 50% by either echocardiogram or MUGA.
- Adequate hematological function
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function
- Total bilirubin ≤ 1.25 x upper normal limit (ULN)
- AST, ALT ≤ 3.0 x ULN
- Adequate renal function: Serum creatinine ≤ 1.25 x
- ULN or calculated creatinine clearance ≥ 50 mL/min
Who cannot join
- Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 1 week prior to first study drug administration.
- Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned below).Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that
- not more than 30% of marrow-bearing bone was irradiated
- the last fraction of radiotherapy was administered ≥ 3 weeks prior to first dose of Lapatinib.
- Other primary tumors/hematologic malignancies within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Pre-existing peripheral neuropathy NCI CTCAE grade > 2 at first study drug administration
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- Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases. If suspected, the patient should be scanned by CT or magnetic resonance imaging (MRI) within 28 days prior to first study drug administration to rule out spinal / CNS metastases.
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
- Active infection requiring i.v. antibiotics at first study drug administration.
- Pregnant or lactating females. Pregnancy test to be assessed within 7 days prior to study treatment start.
- Women of childbearing potential (< 2 years after the last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of study drug.
- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
- Current or recent (within 28 days of first study drug treatment) treatment with another investigational drug or participation in another investigational study
- Clinically significant malabsorption syndrome or inability to take oral medication.
- Psychiatric disability judged by the Investigator to be interfering with compliance for oral drug intake.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase II Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients Pretreated With Chemotherapy or Hormonal Treatment in Combination With Lapatinib for Metastatic Disease
The objective of this phase II study is to gain first information on the efficacy (PFS, ORR and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive metastatic breast cancer pretreated with a combination therapy (chemotherapy and/or hormonal therapy) including lapatinib and presenting with tumor progression.
Primary objective is to assess the efficacy with respect to the percentage of patients surviving without disease progression as assessed by RECIST criteria.
Read more
Secondary objectives are to assess the efficacy of the study treatment with respect to the objective response rates as assessed by RECIST criteria version 1.1, the overall survival and to evaluate the safety profile of the combination by recording the adverse events and abnormal laboratory values associated with the study treatments.
The main efficacy endpoints will be investigated both for the intent-to-treat (ITT) population and the per-protocol (PP) population.
Read the detailed description
The objective of this phase II study is to gain first information on the efficacy (PFS, ORR and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive breast cancer pretreated with a combination therapy (chemotherapy, hormonal therapy) including lapatinib for metastatic disease.
The sample size is not based on statistical consideration. Thirty 30 patients are considered appropriate for a phase II study to gain first information on the efficacy and safety of the study treatment in the study indication.
Only descriptive statistical methods will be used to summarize the study results. Kaplan-Meier estimates will be calculated for PFS and OS. Median PFS and OS time and corresponding two sided 95% confidence intervals will be provided.
Categorical endpoints will be summarized in frequency tables and 95% confidence intervals will be calculated for the objective response rate (ORR) using RECIST.
All safety variables will be summarized descriptively The incidence of adverse events will be summarized by MedDRA terms in a descriptive manner.
The progression free survival time (PFS) is the primary efficacy endpoint of the study. Secondary outcomes are overall survival (OS) and objective response rates (ORR) using RECIST.
Safety outcomes are adverse events, safety laboratory data, physical examinations, vital signs, LVEF, ECG data and ECOG performance status
Definitions:
The objective response rate is the rate of subjects with complete response (CR) or partial response (PR).
Progression-free survival:
The time to progression or death is defined as the time from study entry until the first observation of disease progression or death due to any cause (whichever occurred earlier). Only those death will be considered, which occurs within 84 days of the last tumor assessment or study entry (whichever is later).
If a patient has no progression before a clinical cut-off or the death date is beyond the above-mentioned time interval after last tumor assessment, time to progression/death is censored on the date of last tumor assessment or study entry (in case of no post-baseline tumor assessment).
Overall survival will be calculated from study entry until death. For patients lost to follow-up, data will be censored at the time the patient was last determined to be alive.
As efficacy data of vinorelbine plus lapatinib are not available so far and the current protocol is applied as 2nd or 3rd line therapy for metastatic disease an ORR from 30-40% and a median PFS from 4-6 months is expected.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Lapatinib, Vinorelbine
- Keywords
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapatinib, VinorelbineDrug
Lapatinib 1250mg orally once daily continuously
plus
Vinorelbine 20 mg/m2 intravenously (IV) once weekly [Days 1 and 8] for 2 weeks, followed by a rest week in a 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| lapatinib, vinorelbine | Experimental | Drug: Lapatinib, Vinorelbine Lapatinib 1250mg orally once daily continuously
plus
Vinorelbine 20 mg/m2 intravenously (IV) once weekly [Days 1 and 8] for 2 weeks, followed by a rest week in a 3-week cycle. Receives: Drug: Lapatinib, Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive Free Survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 4 years
Secondary outcomes (2)
Objective Response Rate using RECIST (vers 1.1)
- assess the efficacy of the study treatment with respect to the objective response rates as assessed by RECIST criteria version 1.1 the overall survival
- evaluate the safety profile of the combination by recording the adverse events and abnormal laboratory values associated with the study treatments.
Measured: 4 years
Overall survival (OS)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central European Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Istvan Lang, MD, Principal investigator, National Institute of Oncology Rath Gyorgy u. 7-9. 1122 Budapest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161368
- Sponsor's protocol ID
- CECOG/BC.1.2.001
- Status last verified
- May 2014
- First submitted
- 27 May 2010
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients Pretreated With Chemotherapy or Hormonal Treatment in Combination With Lapatinib for Metastatic Disease
- ClinicalTrials.gov ID
- NCT01161368
- Acronym / sponsor ID
- CECOG/BC.1.2.001
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Central European Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Jul 2010 (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.
The objective of this phase II study is to gain first information on the efficacy (PFS, ORR and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive metastatic breast cancer pretreated with a combination therapy (chemotherapy and/or hormonal therapy) including lapatinib and presenting with tumor progression.
Primary objective is to assess the efficacy with respect to the percentage of patients surviving without disease progression as assessed by RECIST criteria.
Secondary objectives are to assess the efficacy of the study treatment with respect to the objective response rates as assessed by RECIST criteria version 1.1, the overall survival and to evaluate the safety profile of the combination by recording the adverse events and abnormal laboratory values associated with the study treatments.
The main efficacy endpoints will be investigated both for the intent-to-treat (ITT) population and the per-protocol (PP) population.
Detailed description
The objective of this phase II study is to gain first information on the efficacy (PFS, ORR and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive breast cancer pretreated with a combination therapy (chemotherapy, hormonal therapy) including lapatinib for metastatic disease.
The sample size is not based on statistical consideration. Thirty 30 patients are considered appropriate for a phase II study to gain first information on the efficacy and safety of the study treatment in the study indication.
Only descriptive statistical methods will be used to summarize the study results. Kaplan-Meier estimates will be calculated for PFS and OS. Median PFS and OS time and corresponding two sided 95% confidence intervals will be provided.
Categorical endpoints will be summarized in frequency tables and 95% confidence intervals will be calculated for the objective response rate (ORR) using RECIST.
All safety variables will be summarized descriptively The incidence of adverse events will be summarized by MedDRA terms in a descriptive manner.
The progression free survival time (PFS) is the primary efficacy endpoint of the study. Secondary outcomes are overall survival (OS) and objective response rates (ORR) using RECIST.
Safety outcomes are adverse events, safety laboratory data, physical examinations, vital signs, LVEF, ECG data and ECOG performance status
Definitions:
The objective response rate is the rate of subjects with complete response (CR) or partial response (PR).
Progression-free survival:
The time to progression or death is defined as the time from study entry until the first observation of disease progression or death due to any cause (whichever occurred earlier). Only those death will be considered, which occurs within 84 days of the last tumor assessment or study entry (whichever is later).
If a patient has no progression before a clinical cut-off or the death date is beyond the above-mentioned time interval after last tumor assessment, time to progression/death is censored on the date of last tumor assessment or study entry (in case of no post-baseline tumor assessment).
Overall survival will be calculated from study entry until death. For patients lost to follow-up, data will be censored at the time the patient was last determined to be alive.
As efficacy data of vinorelbine plus lapatinib are not available so far and the current protocol is applied as 2nd or 3rd line therapy for metastatic disease an ORR from 30-40% and a median PFS from 4-6 months is expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lapatinib, vinorelbine | Experimental | Drug: Lapatinib, VinorelbineDrug: Lapatinib, Vinorelbine Lapatinib 1250mg orally once daily continuously plus Vinorelbine 20 mg/m2 intravenously (IV) once weekly [Days 1 and 8] for 2 weeks, followed by a rest week in a 3-week cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Written informed consent obtained prior to any study-specific procedure.
- Females ≥18 years.
- Histologically or cytologically confirmed, HER2-positive (HER+++ or HER++ and FISH positive), adenocarcinoma of the breast with measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent.
- Presence of at least one measurable lesion according to RECIST Criteria version 1.1. (target lesion(s) must not lie within an irradiated area)
- Able to comply with the protocol.
Key exclusion criteria (16 listed)
- Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 1 week prior to first study drug administration.
- Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned below).Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that
- not more than 30% of marrow-bearing bone was irradiated
- the last fraction of radiotherapy was administered ≥ 3 weeks prior to first dose of Lapatinib.
- Other primary tumors/hematologic malignancies within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
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 |
|---|---|---|
| Lapatinib, VinorelbineLapatinib 1250mg orally once daily continuously plus Vinorelbine 20 mg/m2 intravenously (IV) once weekly [Days 1 and 8] for 2 weeks, followed by a rest week in a 3-week cycle. | Drug | lapatinib, vinorelbine |
Primary outcome
Progressive Free Survival
Time frame: 4 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
2 secondary outcomes
Objective Response Rate using RECIST (vers 1.1)
Time frame: 4 years
Overall survival (OS)
Time frame: 4 years
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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.
Istvan Lang, MD principal investigator
National Institute of Oncology Rath Gyorgy u. 7-9. 1122 Budapest
2 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 Lapatinib, Vinorelbine in people with Metastatic Breast Cancer, run by Central European Cooperative Oncology Group at 2 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 18 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Hungary. 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 was stopped early (reason given: poor recruitment). Results are not available in the source record.
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?
Progressive Free Survival (time frame: 4 years). 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 13 Aug 2015.