Phase I Study of Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases
Sponsor study identifier
interventional
11
1 country
9
Study Start
January 6, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 22, 2021
Actual (reported)Study Completion
January 22, 2021
Actual (reported)The purpose of this study is to see if capecitabine can be taken safely with different doses of lapatinib in patients with HER-2 positive breast cancer involving brain (brain metastases) and/or in spinal fluid (leptomeningeal disease).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 22, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 6, 2016
Actual (reported)January 6, 2016
Date type not reportedThis date has not been verified as actual or estimated.
January 8, 2016
Actual (reported)January 22, 2021
Actual (reported)January 22, 2021
Actual (reported)maximum tolerated dose (MTD)
During the standard 3+3, the probability that dose escalation will occur at any stage during MTD determination is a function of the underlying DLT rate at the current dose level. This probability can be calculated as the sum of the binomial probabilities of the following two outcomes that would permit escalation to occur: 1. No DLT observed in the first three patients. 2. One DLT is observed in the first three patients followed by no DLT observed in three additional patients at the same dose level.
first 28-day cycle
A minimum of one patient at each dose level will be enrolled. Patients will receive a 4 week treatment cycle consisting of lapatinib 3 day on/11 day off in tandem with capecitabine 7 day on/7 day off with lapatinib. Both drugs will be administered orally as outpatient. Safety, toxicity, and DLT will be assessed weekly during the cycle 1 (first 4 weeks). Each patient will be monitored during cycle 1 prior to enrolling the next patient to the next higher dose level. Dose escalation will take place if no DLT or less than two occurrences of grade 2 toxicity (except those listed below) is observed within a given patient. In the event that a second instance of separate grade 2 toxicity (except those listed below) is noted, the cohort will be expanded to 3 patients at the same dose level and the study will revert to the standard 3+3 design with 3 patients per cohort. There will be no intra-patient dose escalation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Lapatinib in Tandem With Capecitabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUniversity of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432, United States
Memorial Sloan Kettering Cancer Center
Morikawa A, de Stanchina E, Pentsova E, Kemeny MM, Li BT, Tang K, Patil S, Fleisher M, Van Poznak C, Norton L, Seidman AD. Phase I Study of Intermittent High-Dose Lapatinib Alternating with Capecitabine for HER2-Positive Breast Cancer Patients with Central Nervous System Metastases. Clin Cancer Res. 2019 Jul 1;25(13):3784-3792. doi: 10.1158/1078-0432.CCR-18-3502. Epub 2019 Apr 15.
Andrew Seidman, MD
Memorial Sloan Kettering Cancer Center
11 participants (actual enrollment reported by the registry).
First Submitted
January 6, 2016
First Posted
January 8, 2016
Study Start
January 6, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer
Contact the study team to confirm eligibility.
New York, New York, 10065, United States
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Primary Completion
January 22, 2021
Actual (reported)Study Completion
January 22, 2021
Actual (reported)Last Updated
January 26, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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