Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02650752
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib in Tandem With Capecitabine — DRUG

Study Details

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).

Key Dates

Start date
Jan 6, 2016
Status verified
Jan 2021
Primary completion
Jan 22, 2021
Completion
Jan 22, 2021

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib in Tandem With Capecitabine
    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.

Primary Outcome Measure

maximum tolerated dose (MTD) [ Time Frame: first 28-day cycle ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Michigan Health SystemAnn ArborMichigan48109-
Memoral Sloan Kettering Cancer CenterBasking RidgeNew Jersey--
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer Center @ SuffolkCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Queens Cancer Center of Queens HospitalJamaicaNew York11432-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering at Mercy Medical CenterRockville CentreNew York--
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Ann Arbor, MI

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Michigan Health System· Ann Arbor, MIMemoral Sloan Kettering Cancer Center· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Cancer Center @ Suffolk· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYQueens Cancer Center of Queens Hospital· Jamaica, NY

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