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Tykerb (Lapatinib) - Summary

 
 



TYKERB SUMMARY

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.


See all Tykerb indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tykerb (Lapatinib)

New Oncotype DX® data further demonstrate the practice-changing impact of the test in guiding the treatment of early stage breast cancer
Source: Breast Cancer News From Medical News Today [2014.12.18]
Genomic Health announced presentation of the first prospective outcomes data from a large adjuvant study with the Oncotype DX breast cancer test at the recent 2014 San Antonio Breast Cancer...

Male and female breast cancers are not identical
Source: Breast Cancer News From Medical News Today [2014.12.18]
Results of the EORTC10085/TBCRC/BIG/NABCG International Male Breast Cancer Program conducted in both Europe and in the United States and presented at the 2014 San Antonio Breast Cancer Symposium...

No association found between migraine and breast cancer in a pooled analysis of prospective cohort studies
Source: Breast Cancer News From Medical News Today [2014.12.18]
Migraine was not associated with breast cancer risk or differences in the endogenous sex hormones that have been proposed to be associated with migraines, according to a new study published in the...

Targeting androgen in breast cancer
Source: Breast Cancer News From Medical News Today [2014.12.17]
Three studies presented by University of Colorado Cancer Center researchers at the San Antonio Breast Cancer Symposium 2014 demonstrate the effects of blocking androgen receptors in breast cancer.

Herceptin for HER2-positive breast cancer improves long-term survival
Source: Breast Cancer News From Medical News Today [2014.12.16]
A new study shows that when added to chemotherapy, trastuzumab - commonly known as Herceptin - significantly improves long-term survival of HER2-positive breast cancer patients.

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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. [2014]
factor receptor 2 (HER2) -negative operable breast cancer... CONCLUSION: The combination of letrozole-lapatinib in early breast cancer was

Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. [2013]
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. [2012]
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.

Lapatinib activity in premalignant lesions and HER-2-positive cancer of the breast in a randomized, placebo-controlled presurgical trial. [2011.08]
Dual epidermal growth factor receptor (EGFR) and HER2 targeting with the tyrosine kinase inhibitor lapatinib is approved for treating advanced HER2-positive breast cancer and can prevent estrogen receptor (ER)-negative mammary tumors in HER2 transgenic mouse models... In conclusion, short-term lapatinib decreased cell proliferation in DIN, DH, and invasive HER-2-positive (especially ER-negative) breast cancer, thus providing the rationale for further clinical development of lapatinib for breast cancer prevention in high-risk patients, including those with HER-2-positive DIN.

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Clinical Trials Related to Tykerb (Lapatinib)

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer [Recruiting]
The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

Preoperative Chemotherapy With Paclitaxel, Gemcitabine, and Lapatinib (Tykerb´┐Ż) (PGT) [Recruiting]
Primary objectives :

1. To evaluate the recommended dose of the combination of paclitaxel, gemcitabine, and lapatinib (Tykerb«) (PGT) as preoperative chemotherapy in patients with HER2 positive operable breast cancer

Secondary objectives :

1. To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of PGT

2. To determine the safety profile

3. To assess pCR in primary tumor and axillary LN

4. To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS)

5. To assess breast conserving rate after preoperative PGT

Lapatinib and Cetuximab in Patients With Solid Tumors [Recruiting]
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.

Lapatinib in Metastatic Breast Cancer Resistant to Hormone Therapy [Recruiting]
Two thirds or more of breast cancers are dependent on estrogen for growth. We use a number of estrogen-blocking medicines for treatment of metastatic breast cancer. The treatment response to these agents is unpredictable, however, and approximately one-third of patients with metastatic breast cancer with receptors for estrogen or progesterone have no benefit from hormonal therapy. Nearly all patients with metastatic breast cancer will eventually become resistant to hormonal therapy despite the fact that the hormone receptors are still present.

Some cells make a different class of growth factor receptor called the Epidermal Growth Factor Receptor. There is a growing body of experimental evidence showing that breast cancer cells that make Epidermal Growth Factor Receptors are more resistant to hormonal therapy and have a poorer prognosis. Several investigators have found that the Epidermal Growth Factor Receptor can activate the estrogen receptor, even in the presence of estrogen-blocking drugs. Growth of these cells can be slowed by blockade of both Epidermal Growth Factor Receptor signaling and estrogen-receptor signaling. Lapatinib is a small molecule which can inhibit two different forms of the Epidermal Growth Factor Receptor. It has been studied in people with a number of different cancers, including breast cancer, and a safe dose and its common side effects have been defined.

Our hypothesis is that the Epidermal Growth Factor Receptor is the dominant receptor pathway used by breast cancers in our patients with hormone-resistant tumors. Drugs like lapatinib which block several forms of the Epidermal Growth Factor Receptor would best be able to reverse resistance to hormonal agents.

Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer [Recruiting]
This is a phase I/II study to determine the safety and gain insight into the immune response of the immunologic agent dHER2+AS15 ASCI when administered in combination with lapatinib. This study is for patients with metastatic breast cancer (invasive breast cancer with stage IV disease) that overexpresses HER2 and is resistant to trastuzumab (Herceptin).

The dHER2 + AS15 candidate Antigen-Specific Cancer Immunotherapeutic (ASCI) contains a recombinant protein termed dHER2, which is a truncated version of the HER2 protein. HER2 is a protein that is commonly overexpressed in breast cancer. This protein is combined with the immunological adjuvant AS15 Adjuvant System from GSK (GlaxoSmithKline), which is a liposomal formulation containing three immunostimulatory components.

Lapatinib is FDA approved for use in combination with capecitabine for the treatment of subjects with advanced or metastatic breast cancer whose tumors overexpress HER2.

more trials >>

Reports of Suspected Tykerb (Lapatinib) Side Effects

Diarrhoea (332)Death (117)Nausea (106)Fatigue (87)Palmar-Plantar Erythrodysaesthesia Syndrome (84)Rash (66)Vomiting (60)Decreased Appetite (46)Erythema (44)Disease Progression (44)more >>


Page last updated: 2014-12-18

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