TYKERB « (lapatinib) tablets
Lapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors.
TYKERB is indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
Media Articles Related to Tykerb (Lapatinib)
Scripps Florida scientists predict cell changes that affect breast cancer growth, opening door to more effective therapies
Source: Breast Cancer News From Medical News Today [2016.04.29]
Designing effective new drugs, especially drugs to fight cancer, demands that you know as much as you can about the molecular workings of cancer growth.
A long-noncoding RNA regulates repair of DNA breaks in triple-negative breast cancer cells
Source: Breast Cancer News From Medical News Today [2016.04.29]
Findings give 'new insight' into biology of tough-to-treat breast cancer.The discovery of long non-coding RNA (lncRNA) has dramatically changed the understanding of the biology of diseases such...
Metastectomies: Local Approaches to Breast Cancer Metastases
Source: Medscape General Surgery Headlines [2016.04.28]
In expert panel reported on the increasing the use of radiation therapy and surgery to control low-volume metastatic disease in patients with breast cancer, as part of the 2016 EBCC in Amsterdam.
Big Data vs Breast Cancer Trials Raises Big Issues
Source: Medscape Hematology-Oncology Headlines [2016.04.27]
Using big data in place of clinical trials to answer clinical questions may sound progressive. But judging from the results of a recent study, it raises big issues, says Dr Kathy Miller.
Vanderbilt-Ingram Cancer Center-led study finds explanation for some treatment-resistant breast cancers
Source: Breast Cancer News From Medical News Today [2016.04.27]
A targeted therapy for triple-negative breast cancer (TNBC), the most aggressive form of breast cancer, has shown potential promise in a recently published study.
Published Studies Related to Tykerb (Lapatinib)
Double-blind, placebo-controlled, multicenter, randomized, phase IIb neoadjuvant
study of letrozole-lapatinib in postmenopausal hormone receptor-positive, human
epidermal growth factor receptor 2-negative, operable breast cancer. 
factor receptor 2 (HER2) -negative operable breast cancer... CONCLUSION: The combination of letrozole-lapatinib in early breast cancer was
Endocrine therapy with or without inhibition of epidermal growth factor receptor
and human epidermal growth factor receptor 2: a randomized, double-blind,
placebo-controlled phase III trial of fulvestrant with or without lapatinib for
postmenopausal women with hormone receptor-positive advanced breast cancer-CALGB
40302 (Alliance). 
metastatic breast cancer treated with fulvestrant... CONCLUSION: Adding lapatinib to fulvestrant does not improve PFS or OS in
Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment
of human epidermal growth factor receptor 2-overexpressing metastatic breast
in patients with HER2-overexpressing metastatic breast cancer (MBC)... CONCLUSION: This trial demonstrated that lapatinib combined with paclitaxel
Target-specific, histology-independent, randomized discontinuation study of
lapatinib in patients with HER2-amplified solid tumors. 
focused on the drug target rather than on histology... CONCLUSIONS: Basing trial eligibility on the presence of a genetic target, versus
Effects of lapatinib monotherapy: results of a randomised phase II study in therapy-naive patients with locally advanced squamous cell carcinoma of the head and neck. [2011.08.23]
BACKGROUND: Lapatinib is a dual inhibitor of epidermal growth factor receptor (EGFR) and human EGFR-2 (HER-2) tyrosine kinases. This study investigated the pharmacodynamic and clinical effects of lapatinib in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN)... CONCLUSION: Short-term lapatinib monotherapy did not demonstrate apoptotic changes, but provided evidence of clinical activity in locally advanced SCCHN, and warrants further investigation in this disease.
Clinical Trials Related to Tykerb (Lapatinib)
Regulatory TYKERB´┐Ż Tablets PMS [Completed]
Lapatinib and Cetuximab in Patients With Solid Tumors [Completed]
This trial is for patients with colon cancer, head and neck cancer and lung cancer that has
not responded to standard therapy.
Cetuximab targets a receptor on cancer cells called the Epidermal Growth Factor Receptor or
EGFR. It is thought that this receptor is turned "on" in some cancers, enabling cancer cells
to divide and grow. Blocking this receptor can turn this signal off. Cetuximab blocks this
receptor from the outside of cancer cells. It is thought that cancer cells can turn this
signal back on by the EGFR joining with a related receptor called ErbB2. Lapatinib blocks
both EGFR and ErbB2 from the inside of cancer cells. In laboratory experiments it has been
found that combining drugs that target both EGFR and ErbB2 might work better in turning this
signal back off. The purpose of this study is to determine the maximum dosages that patients
can tolerate when these two medicines are given at the same time.
In addition, in order to be on this trial, patients must agree to have a tumor biopsy before
starting treatment on this study and 21 days after starting treatment. These biopsies are a
required part of the study. Patients must also agree to have blood drawn for research
testing to see whether genetic differences between patients explain different reactions to
and side effects from, these medicines.
A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase [Completed]
This phase II study is a single-arm, two-stage, multicentre study to determine the clinical
activity of lapatinib in combination with pemetrexed in patients with Non-Small Cell Lung
Cancer (NSCLC) who have received one prior cytotoxic chemotherapy regimen. There will be a
short safety run in portion of the study to determine the optimal treatment regimen (OTR)
for the combination, since these two drugs have not previously been used together.
Approximately 27 patients will be enrolled into the first stage of the study and if
sufficient responses are seen an additional 27 patients will be enrolled into the second
stage giving an overall evaluable patient number of 54. Patients will be treated with
pemetrexed plus lapatinib at the determined OTR to disease progression, death or withdrawal
from the study treatment for any reason.
Safety and efficacy assessments will be performed on all patients at 6-week intervals, as
well as at the end of treatment. Patients withdrawn from study treatment with stable disease
will be assessed every 6 weeks until progression. Thereafter, patients will be followed for
survival at approximately 12-week intervals until death or to a maximum of 5 years after
last patient is enrolled, whichever comes first.
Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer [Active, not recruiting]
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.
Lapatinib With Sirolimus or Metformin [Active, not recruiting]
The goal of this clinical research study is to find the highest tolerable dose of 2
different combinations of drugs that can be given to patients with advanced cancer. The
first combination of drugs is Tykerb (lapatinib) and Rapamune (sirolimus), and the second
combination is lapatinib and Glucophage (metformin). The safety of these drug combinations
will also be studied.
Reports of Suspected Tykerb (Lapatinib) Side Effects
Palmar-Plantar Erythrodysaesthesia Syndrome (84),
Decreased Appetite (46),
Disease Progression (44), more >>
Page last updated: 2016-04-29