Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab (LV)
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|ClinicalTrials.gov Identifier: NCT01730677|
Recruitment Status : Unknown
Verified March 2014 by Jungsil Ro, National Cancer Center, Korea.
Recruitment status was: Recruiting
First Posted : November 21, 2012
Last Update Posted : March 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Lapatinib Drug: Vinorelbine||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
lapatinib 1000mg, once daily vinorelbine 20mg/m2, D1 and D8, every 3 weeks
lapatinib 1000mg, once daily
Other Name: LV armDrug: Vinorelbine
Vinorelbine 20mg/m2, D1 and D8, every 3 weeks
Other Name: LV arm
No Intervention: Vinorelbine
vinorelbine 30mg/m2, D1 and D8, every 3 weeks
- 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.
- 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 ]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).
- Overall survival (OS) [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 36 months ]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.
- 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 ]All toxicities during treatment will be recorded according to NCI-common toxicity criteria for adverse effects version 4.0.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730677
|Contact: Jungsil Roemail@example.com|
|Contact: Inhae Parkfirstname.lastname@example.org|
|Korea, Republic of|
|National Cancer Center||Recruiting|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Contact: Jungsil Ro +82-31-920-1610 email@example.com|
|Contact: Inhae Park +82-31-920-1680 firstname.lastname@example.org|
|Principal Investigator: Jungsil Ro|
|Principal Investigator:||Jungsil Ro||National Cancer Center, Korea|