Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer
Status:
Terminated
Trial end date:
2017-03-20
Target enrollment:
Participant gender:
Summary
Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that
is HER2/neu-positive will take part in this study. This type of breast cancer has a high
amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer
and normal cells. This family of receptors is important for cell growth and is found in many
tumor types. The purpose of this research study is to compare an approved treatment for
breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an
experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic
breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used
to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering
with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered
"investigational", which means the drug has not been approved by the US Food and Drug
Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may
slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However,
this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine
may help stop cancer cells as well as or better than capecitabine alone. Other studies have
demonstrated activity and tolerability of lapatinib either alone or in combination with
capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and
lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All
medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day
1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken
daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take
lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue
to receive these medications unless they experience severe, serious and/or excessive side
effects, the cancer becomes worse, the subjects wishes to no longer participate or the study
doctor feels it is not in the best interest to continue treatment.Tests and procedures such
as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at
one or more of the following time points: before the study starts, before each cycle, every 6
and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborators:
National Cancer Institute (NCI) Rutgers Cancer Institute of New Jersey