Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT01499160
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • letrozole — DRUG
    Drug is are to be taken orally. 2.5 mg once daily
  • lapatinib — DRUG
    Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)
  • everolimus — DRUG
    Drug is to be taken orally. 5 mg once daily.

Study Details

About a third of patients with breast cancer are usually treated by hormone pills called tamoxifen and aromatase inhibitors. Aromatase inhibitors are drugs that stop female hormone production. Female hormone or estrogen is an important hormone for the growth of breast cancer cells. Letrozole is one of the aromatase inhibitors that is approved by the FDA and has been used to treat breast cancer since 1997. However, hormone pills usually work for about 6-10 months in most patients. Later on, breast cancer will start to grow again. This condition when hormone pills or endocrine therapy no longer work is called "endocrine resistant" breast cancer. The scientists here at University of Maryland have discovered how these cancer cells can become resistant to hormone pills. In our laboratory tests, the investigators found that lapatinib and everolimus can reverse this resistance and make letrozole work again. However, it is not known if the drugs can reverse the resistance in humans. The purpose of this study is to find out whether the combination of letrozole, lapatinib, and everolimus is effective in women with breast cancer when hormone pills no longer work. Lapatinib is an anti-cancer drug that is already approved by the Food and Drug Administration (FDA). It is the standard of care for the treatment of a particular type of breast cancer called human epithelial growth factor receptor 2 (HER2)-positive breast cancer. HER2 is a protein involved in the growth of some cancer cells. This study will also include patients with HER2-negative breast cancer. This means that the cancer cells in these patients do not depend on the HER2 protein. The use of lapatinib in these patients is considered experimental. Everolimus is also an anti-cancer drug that is approved by the FDA for kidney cancer. Initial studies in mice and later studies in women with breast cancer have shown that everolimus may also slow the growth of breast cancer. The use of everolimus is experimental in this study.

Key Dates

Start date
May 31, 2012
Status verified
Feb 2022
Primary completion
Nov 30, 2014
Completion
Dec 31, 2016

Study Design

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

Arms

  • Experimental: HER2-positive or negative
    Lapatinib 1,500 mg/day + letrozole 2.5 mg/day until progression followed by everolimus 5 mg/day + letrozole 2.5 mg/day + lapatinib 1,250 mg/day.

Primary Outcome Measure

Clinical Benefit Rate of Patients Treated With the Combination of Letrozole and Lapatinib and Then After Progression, Treated With Everolimus, Letrozole and Lapatinib. [ Time Frame: From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Marlene & Stewart Greenebaum Cancer CenterBaltimoreMaryland21201-

Find similar trials in Baltimore, MD

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Maryland Marlene & Stewart Greenebaum Cancer Center· Baltimore, MD

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