Lapatinib and RAD-001 for HER2 Positive Metastatic Breast Cancer

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT01283789
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Lapatinib and RAD-001 — DRUG
    Lapatinib will be taken orally as a once-daily dose of 1250 mg (five 250 mg tablets) continuously from study day 1 until progression of disease. Patients will take the tablet at bedtime, at the same time each day, in a fasting state. Everolimus will be taken orally as a once-daily dose of 5 mg (one 5 mg tablet) from study day 1 until progression of disease. Patients will take the tablet at the same time each morning.

Study Details

By doing this study, researchers hope to learn the effectiveness of the combination of Lapatinib and RAD-001 for treating patients who have progressed on previous therapies.

Key Dates

Start date
Feb 28, 2011
Status verified
Feb 2017
Primary completion
Apr 30, 2016
Completion
Apr 30, 2017

Study Design

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

Arms

  • Experimental: Lapatinib and RAD-001
    RAD-001 will be administered orally as a once-daily dose of 5 mg (one 5 mg tablet) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD-001 in the morning, at the same time each day. Lapatinib will be administered orally as a once-daily dose of 1250 mg (five 250 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take lapatinib at bedtime, at the same time each day. Lapatinib should be taken by the patient in a fasting state.

Primary Outcome Measure

Assess the effectiveness of the combination of RAD-001 and lapatinib [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CentnerKansas CityKansas66160-

Find similar trials in Kansas City, KS

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Kansas Medical Centner· Kansas City, KS

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