NEWS HIGHLIGHTSMedia Articles Related to Tykerb (Lapatinib)
Secretary Sebelius Statement On New Breast Cancer Recommendations
Source: Health News from Medical News Today [2009.11.19]
HHS Secretary Kathleen Sebelius issued the following statement today on new breast cancer screening recommendations from the U.S. Preventive Services Task Force: "There is no question that the U.S. Preventive Services Task Force Recommendations have caused a great deal of confusion and worry among women and their families across this country. I want to address that confusion head on. The U.S.
Breast Cancer Campaign: New Breast Cancer Research Funding For Belfast
Source: Health News from Medical News Today [2009.11.19]
Individualised radiotherapy treatment based on a person's genetic make up could soon become a reality, according to Breast Cancer Campaign. Professor Kevin Prise from Queen's University Belfast has been awarded a three year project grant by the charity to study how genes are involved in the effectiveness of radiotherapy treatment for breast cancer.
Some Physicians Say New Breast Cancer Screening Guidelines Unlikely To Alter Their Practices
Source: Health News from Medical News Today [2009.11.19]
One day after the release of new breast cancer screening guidelines, many physicians and some medical groups are saying that they do not plan to adopt the new recommendations -- which represent a drastic change -- the New York Times reports (Belluck, New York Times, 11/18). The guidelines, released by the U.S.
Radiation Breakthrough Gives Breast Cancer Patients Hope In Single Dose
Source: Breast Cancer News From Medical News Today [2009.11.19]
A radiation breakthrough to treat breast cancer patients in one day, as opposed to the current average of six weeks, has arrived at Cancer Treatment Centers of America(R) (CTCA) in Philadelphia. CTCA will become the first in the country to offer this treatment option using the Novac7 technology from Rome, Italy.
Breast Cancer Screening: New Fuel for an Old War of Words and Data
Source: MedPageToday.com - medical news plus CME for physicians [2009.11.19]
A controversy that has alternately simmered and boiled for more than 40 years reached a flash point this week when the U.S. Preventive Services Task Force published recommendations for breast cancer screening with mammography.
Published Studies Related to Tykerb (Lapatinib)
Estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2 (HER2), and epidermal growth factor receptor expression and benefit from lapatinib in a randomized trial of paclitaxel with lapatinib or placebo as first-line treatment in HER2-negative or unknown metastatic breast cancer. [2009.08.20]
PURPOSE: Lapatinib is a dual inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) with activity in HER2-amplified metastatic breast cancer (MBC). Its role in non-HER2-amplified MBC remains unclear. EGF30001, a phase III trial of lapatinib and paclitaxel versus paclitaxel and placebo, demonstrated lapatinib does not significantly benefit HER2-negative or HER2-unselected patients with MBC. Published data support interactions between steroid hormone and peptide growth factor signaling. We hypothesized that molecular subgroups may exist within EGF30001 that would benefit from lapatinib... CONCLUSION: Although subgroups are small, these analyses support the hypothesis that semiquantitative determination of hormone receptor status may be a surrogate for EGFR and/or HER2 dependency.
Effects of ketoconazole and carbamazepine on lapatinib pharmacokinetics in healthy subjects. [2009.04]
AIMS: To characterize the impact of potent CYP3A4 inhibition and induction on lapatinib pharmacokinetics... CONCLUSIONS: Systemic exposure to lapatinib was significantly altered by potent inhibition and induction of CYP3A4. Dose adjustments may be required when lapatinib is administered with orally administered drugs that potently alter the activity of this enzyme.
Effects of food on the relative bioavailability of lapatinib in cancer patients. [2009.03.10]
PURPOSE: This study was conducted to characterize the effect of food on the relative bioavailability of lapatinib... CONCLUSION: These large increases in lapatinib bioavailability and absolute variability support the recommendation for dosing in the fasted state to achieve consistent therapeutic exposure. Prescribers and patients should consider the potential consequences of toxicity or diminished efficacy that might result from dosing without regard to variations in diet.
Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for metastatic breast cancer. [2008.12.01]
PURPOSE: Lapatinib, a dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR/ErbB1) and human epidermal growth factor receptor 2 (HER-2/ErbB2), is effective against HER-2-positive locally advanced or metastatic breast cancer (MBC). This phase III trial evaluated the efficacy of lapatinib in HER-2-negative and HER-2-uncharacterized MBC... CONCLUSION: Patients with HER-2-negative or HER-2-untested MBC did not benefit from the addition of lapatinib to paclitaxel. However, first-line therapy with paclitaxel-lapatinib significantly improved clinical outcomes in HER-2-positive patients. Prospective evaluation of the efficacy and safety of this combination is ongoing in early and metastatic HER-2-positive breast cancer patients.
A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. [2008.12]
PURPOSE: Lapatinib is a small molecule, dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor type 2 (HER2). Initial results of a phase III trial demonstrated that lapatinib plus capecitabine is superior to capecitabine alone in women with HER2-positive advanced breast cancer that progressed following prior therapy including trastuzumab. Updated efficacy and initial biomarker results from this trial are reported... CONCLUSION: The addition of lapatinib to capecitabine provides superior efficacy for women with HER2-positive, advanced breast cancer progressing after treatment with anthracycline-, taxane-, and trastuzumab-based therapy. Biomarker studies could not identify a subgroup of patients who failed to benefit from the addition of lapatinib to capecitabine.
Clinical Trials Related to Tykerb (Lapatinib)
Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer [Recruiting]
This study is being conducted to compare the efficacy and safety of pazopanib in combination
with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic
breast cancer whose tumors overexpress the ErbB2 protein.
Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical Cancer [Recruiting]
This study is being conducted to compare the efficacy and safety of pazopanib in combination
with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic
cervical cancer
Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-Line Therapy in HER2/Neu-Positive Breast Cancer [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.
A Phase I Study Of Oral Topotecan And Lapatinib In Subjects With Advanced Solid Tumors [Not yet recruiting]
This is an open-label, Phase I study of oral topotecan administered in combination with
lapatinib in subjects with advanced solid tumors. This Phase I study will evaluate the
safety, tolerability, and pharmacokinetics of oral topotecan administered in combination with
lapatinib. This study will be conducted in two parts. Part 1 of the study will investigate
the impact of lapatinib on the bioavailability of oral topotecan (bioavailability phase) and
Part 2 of the study will consist of dose finding to determine the maximum-tolerated dose
(MTD) regimen of the combination (dose escalation phase). In Part 2 of the study, the dose
of oral topotecan will be escalated while lapatinib will be given initially as fixed doses.
The primary objective of the study is to determine the MTD regimen of oral topotecan
administered for five-consecutive days every 21 days in combination with daily lapatinib in
subjects with advanced solid tumors.
A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) Versus Pemetrexed in Advanced Non Small Cell Lung Cancer [Not yet recruiting]
This phase II study is a randomised, open-label, parallel group, multicenter study to
determine the clinical activity of lapatinib in combination pemetrexed in patients with NSCLC
who have received one prior platinum containing chemotherapy regimen. There will be a short
safety run in portion of the study to determine the optimal treatment regimen for the
combination, since these two drugs have not previously been used together.
Two hundred (200) patients will be randomised in a 1: 1 ratio to receive either of the two
treatment groups (pemetrexed plus lapatinib at the OTR vs 500 mg/m2 IV pemetrexed alone),
stratified by tumour histology (squamous versus adenocarcinoma) and performance status (0, 1
vs 2). Subjects will be treated to disease progression or withdrawal from the study for any
reason.
Safety and efficacy assessments will be performed on all subjects at 6-week intervals, as
well as at the end of treatment. Subjects withdrawn from the study with stable disease will
be assessed every 6 weeks until progression. Thereafter, subjects 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.
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