Metastatic Breast CancerPhase 2LVNCT01730677
Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab
A Phase 2 study testing Lapatinib and Vinorelbine in people with Metastatic Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The investigators address the clinical efficacy of continuing lapatinib treatment combined with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared with vinorelbine alone in HER2 positive metastatic breast cancer patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Lapatinib and Vinorelbine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Dec 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed stage IV or recurrent breast cancer
- Documented HER2 status and positive for HER2 in tumor cells by immunohistochemistry (3+) or FISH (The results of SISH or CISH are also allowed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age ≥ 20 years
- Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1
- Patients who were treated with anthracycline based regimens in the adjuvant/neoadjuvant or metastatic setting.
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- Patients who experienced disease progression after the treatment with lapatinib containing regimens whose response were more than stable disease (including CR, PR, SD≥ 12 weeks) during treatment. There is no limitation on the time interval between the stop of lapatinib treatment and the study enrollment.
- Patients must have received 2 or 3 lines of prior anti-HER2 therapy in metastatic setting as follows regardless of the order
- In case with trastuzumab: monotherapy or combined with taxane or combined with AI
- In case with lapatinib: monotherapy or combined with capecitabine or combined with AI
- Patients who received T-DM1 or pertuzumab with trastuzumab previously are allowed in this study
- Patients who received neratinib, mTOR inhibitor, PI3K/AKT inhibitor, or BIBW2992 are not eligible
- Patients who experienced a disease recurrence during receiving adjuvant trastuzumab or within 6 months after the completion of adjuvant trastuzumab treatment are allowed even when patients did not receive trastuzumab in the metastatic setting.
- Patients who experienced a disease recurrence during receiving adjuvant lapatinib or within 6 months after the completion of adjuvant lapatinib treatment are allowed as long as they meet criteria of CR, PR or SD ≥ 12 weeks by lapatinib/capecitabine treatment for metastatic disease.
- Central nervous system metastasis is permitted if asymptomatic or controlled with minimal steroid requirement and is documented to be non-progressing at study entry.
- Negative urine pregnancy test within 7 days prior to registration in premenopausal patients
- Baseline LVEF ≥50% measured by echocardiogram or multiple gated acquisition scan (MUGA) scan
- Adequate hematopoietic function: Absolute granulocyte count ≥1,500/mm3, platelet≥100,000/mm3, hemoglobin≥9g/mm3
- Adequate hepatic function: total bilirubin ≤1.5mg/dL, AST/ALT≤2 x upper normal limit (UNL), alkaline phosphatase ≤2.5 x UNL, in case with bone metastases alkaline phosphatase ≤5 x UNL
- Adequate renal function: Serum creatinine ≤1.5mg/dL
- Ability to understand and comply with protocol during study period
- Patients should sign a written informed consent before study entry
Who cannot join
- Pregnant or lactating women or women of childbearing potential, including women whose last menstrual period was ,12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during the study treatment period.
- Patients who received vinorelbine treatment in metastatic setting.
- Patients who received more than 3 lines of prior anti-HER2 therapy in metastatic setting
- Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled GI disease (e.g., Crohn's disease, ulcerative colitis)
- 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)
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- Concurrent disease or serious medical disorder,
- Serious cardiac illness :
- History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <50%) High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade atrioventricular (AV)-block,supraventricular arrhythmias, prolonged corrected QT (QTc) which are not adequately rate-controlled) Angina pectoris requiring antianginal medication Clinically significant valvular heart disease Evidence of transmural infarction on ECG Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg)
- known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Jungsil Ro, +82-31-920-1610, jungsro@ncc.re.kr
Inhae Park, +82-31-920-1680, parkih@ncc.re.kr
About this study
Official title: Randomized Phase II Study of Lapatinib Plus Vinorelbine Versus Vinorelbine in Patients With HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib and Trastuzumab Treatment
The investigators address the clinical efficacy of continuing lapatinib treatment combined with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared with vinorelbine alone in HER2 positive metastatic breast cancer patients.
Read the detailed description
This study is a multicenter, randomized, open label, phase II study. Patients will be randomized to either lapatinib plus vinorelbine (LV) arm or vinorelbine alone (V) arm, if they are satisfied by inclusion and exclusion criteria. The stratification factors are followings: 1) visceral metastasis vs. others, 2) previous response to lapatinib treatment, complete response(CR)+partial response(PR) vs. stable disease(SD)≥ 12wks.
Patients in LV arm will receive daily lapatinib 1,000mg with vinorelbine 20mg/m2 day1 and day 8. Patients in V arm will receive vinorelbine 30mg/m2 day 1 and day 8. Treatment repeats every 21 days unless there is any evidence of disease progression or unacceptable toxicity or noncompliance by patient with protocol requirements. Response will be documented by physical examination, chest or abdomen CT prior to treatment as a baseline, and every 2 cycles (window period ± 1 week) after a start of treatment and at 18 weeks.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Lapatinib, Vinorelbine
- Keywords
- Lapatinib, Vinorelbine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapatinibDrug
Also called LV arm
lapatinib 1000mg, once daily
VinorelbineDrug
Also called LV arm
Vinorelbine 20mg/m2, D1 and D8, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lapatinib+Vinorelbine | Experimental | lapatinib 1000mg, once daily vinorelbine 20mg/m2, D1 and D8, every 3 weeks Receives: Drug: Lapatinib; Drug: Vinorelbine |
| Vinorelbine | No intervention | vinorelbine 30mg/m2, D1 and D8, every 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate at 18 weeks
The PFS rate at 18 weeks will be calculated as the ratio of patients on the study to Intent to treat (ITT) population at the time point of 18 weeks from the initiation of study treatment. The ITT population will consist of all patients who are randomized.
Measured: The time point of 18 weeks from the initiation of study treatment.
Secondary outcomes (4)
Progression free survival (PFS)
The secondary objective of this study is to estimate the PFS and OS in both arms and median PFS and OS will be estimated by Kaplan-Meier estimates and compared by log-rank test. Response rate will be calculated as the proportion of patients with a complete or partial tumor response among ITT population. Chi-square test will be used to PFS rate and compare response rates between the two arms (categorical variables).
Measured: From date of randomization until the date of first documented progression, withdrawal from the study, or date of death from any cause, whichever came first, assessed up to 36 months
Overall survival (OS)
The secondary objective of this study is to estimate the OS in both arms will be estimated by Kaplan-Meier estimates and compared by log-rank test.
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months
toxicity
All toxicities during treatment will be recorded according to NCI-common toxicity criteria for adverse effects version 4.0.
Measured: From date of randomization until the date of first documented progression, withdrawal from the study, or date of death from any cause, whichever came first, assessed up to 36 months
response rate
Objective response mean complete response and partial response according to Response evaluation criteria in solid tumors v 1.1 and response will be assessed every 6 weeks.
Measured: From date of randomization until the date of first documented progression, withdrawal from the study, or date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Asan Medical Center, Chung-Ang University, Korea University Anam Hospital, Samsung Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Jungsil Ro, National Cancer Center, Korea
- Investigators
- Jungsil Ro, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730677
- Sponsor's protocol ID
- NCCCTS-11-583
- Acronym
- LV
- Status last verified
- Mar 2014
- First submitted
- 15 Jul 2012
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sim SH, Park IH, Jung KH, Kim SB, Ahn JH, Lee KH, Im SA, Im YH, Park YH, Sohn J, Kim YJ, Lee S, Kim HJ, Chae YS, Park KH, Nam BH, Lee KS, Ro J. Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16). Br J Cancer. 2019 Dec;121(12):985-990. doi: 10.1038/s41416-019-0618-z. Epub 2019 Nov 6.
PubMed 31690831
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Lapatinib Plus Vinorelbine Versus Vinorelbine in Patients With HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib and Trastuzumab Treatment
- ClinicalTrials.gov ID
- NCT01730677
- Acronym / sponsor ID
- LV / NCCCTS-11-583
- Conditions
- Metastatic Breast Cancer
- Keywords
- Lapatinib, Vinorelbine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Asan Medical Center, Chung-Ang University, Korea University Anam Hospital, Samsung Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital
- Study start
- Jul 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Nov 2012 (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 investigators address the clinical efficacy of continuing lapatinib treatment combined with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared with vinorelbine alone in HER2 positive metastatic breast cancer patients.
Detailed description
This study is a multicenter, randomized, open label, phase II study. Patients will be randomized to either lapatinib plus vinorelbine (LV) arm or vinorelbine alone (V) arm, if they are satisfied by inclusion and exclusion criteria. The stratification factors are followings: 1) visceral metastasis vs. others, 2) previous response to lapatinib treatment, complete response(CR)+partial response(PR) vs. stable disease(SD)≥ 12wks.
Patients in LV arm will receive daily lapatinib 1,000mg with vinorelbine 20mg/m2 day1 and day 8. Patients in V arm will receive vinorelbine 30mg/m2 day 1 and day 8. Treatment repeats every 21 days unless there is any evidence of disease progression or unacceptable toxicity or noncompliance by patient with protocol requirements. Response will be documented by physical examination, chest or abdomen CT prior to treatment as a baseline, and every 2 cycles (window period ± 1 week) after a start of treatment and at 18 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lapatinib+Vinorelbine | Experimental | Drug: Lapatinib, Drug: Vinorelbinelapatinib 1000mg, once daily vinorelbine 20mg/m2, D1 and D8, every 3 weeks |
| Vinorelbine | No intervention | –vinorelbine 30mg/m2, D1 and D8, every 3 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Confirmed stage IV or recurrent breast cancer
- Documented HER2 status and positive for HER2 in tumor cells by immunohistochemistry (3+) or FISH (The results of SISH or CISH are also allowed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age ≥ 20 years
- Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1
Key exclusion criteria (10 listed)
- Pregnant or lactating women or women of childbearing potential, including women whose last menstrual period was ,12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during the study treatment period.
- Patients who received vinorelbine treatment in metastatic setting.
- Patients who received more than 3 lines of prior anti-HER2 therapy in metastatic setting
- Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled GI disease (e.g., Crohn's disease, ulcerative colitis)
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 |
|---|---|---|
| LapatinibAlso: LV armlapatinib 1000mg, once daily | Drug | Lapatinib+Vinorelbine |
| VinorelbineAlso: LV armVinorelbine 20mg/m2, D1 and D8, every 3 weeks | Drug | Lapatinib+Vinorelbine |
Primary outcome
Progression free survival rate at 18 weeks
Time frame: The time point of 18 weeks from the initiation of study treatment.
The PFS rate at 18 weeks will be calculated as the ratio of patients on the study to Intent to treat (ITT) population at the time point of 18 weeks from the initiation of study treatment. The ITT population will consist of all patients who are randomized.
4 secondary outcomes
Progression free survival (PFS)
Time frame: From date of randomization until the date of first documented progression, withdrawal from the study, or date of death from any cause, whichever came first, assessed up to 36 months
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
toxicity
Time frame: From date of randomization until the date of first documented progression, withdrawal from the study, or date of death from any cause, whichever came first, assessed up to 36 months
response rate
Time frame: From date of randomization until the date of first documented progression, withdrawal from the study, or date of death from any cause, whichever came first, assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Derived from this study: PubMed 31690831Sim SH, Park IH, Jung KH, Kim SB, Ahn JH, Lee KH, Im SA, Im YH, Park YH, Sohn J, Kim YJ, Lee S, Kim HJ, Chae YS, Park KH, Nam BH, Lee KS, Ro J. Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16). Br J Cancer. 2019 Dec;121(12):985-990. doi: 10.1038/s41416-019-0618-z. Epub 2019 Nov 6.
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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.
Jungsil Ro principal investigator
National Cancer Center, Korea
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 Lapatinib and Vinorelbine in people with Metastatic Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 22 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Mar 2014. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jungsil Ro (+82-31-920-1910, jungsro@ncc.re.rk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival rate at 18 weeks (time frame: The time point of 18 weeks from the initiation of study treatment.). 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 NCT01730677, 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 12 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.