Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Capecitabine

Lapatinib

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Lapatinib (Tyverb) po 1500mg daily d1-21, new cycle will be started on day 22 until progression.

Lapatinib po 1250mg daily d1-21; new cycle will be started on day 22 until progression

Lapatinib plus capecitabine

Florian Lordick, MD

Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a beneficial contribution to current treatment paradigms since preclinical data suggest that lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines, which may contribute to clinical benefit. The study described in this protocol has been designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to search for molecular correlates that may be associated with response to this compound.

The majority of patients with metastatic gastric and gastro-esophageal cancer undergo first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes combined to a taxane), but the role of second-line chemotherapy has not yet been defined. Therefore, progression during or shortly after first-line chemotherapy is a medical condition no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and gastroesophageal cancer make these indications prime candidate for treatment with the dual ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.

Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer

Lapatinib Versus Lapatinib With Capecitabine as Second-line Treatment in Her2-Overexpressing Metastatic Gastro-Esophageal Cancer: A Randomized Phase II Trial

Objective response rate (ORR, complete and partial remission according to RECIST criteria

- all to be confirmed by at least two consecutive tumor response assessments within no shorter than 4 weeks)

recording of AEs/SAEs, vital signs, ECG, LVEF, physical exams, lab values

the definition of biomarkers that are associated with response or resistance to treatment

National Center for Tumor Diseases, Heidelberg

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

pyrotinib(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/ m\^2 BID)

Pyrotinib Plus Capecitabine

Lapatinib (1250 mg once daily)+ capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)

Lapatinib Plus Capecitabine

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC patients, who have prior received taxane and trastuzumab.Patients will be randomized in a 1:1 ratio to one of the following treatment arms.Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily),Arm B: Lapatinib (1250 mg once daily) + capecitabine (1000 mg/m\^2 twice daily).Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawalof consent.

Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)

A Randomised, Open-label, Parallel Controlled, Multicentre, Phase 3 Clinical Trial of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:

From infromed consent to progression or death

Jiangsu HengRui Medicine Co., Ltd.

Mitogens

HER2+ metastatic breast cancer patients treated with lapatinib plus capecitabine

GSK Clinical Trials

This study will describe the treatment paradigm used over recent years in the clinical management of Human Epidermal Growth Factor Receptor 2 (HER2)+ metastatic breast cancer in Hungary. This information will provide insight into real-world exposure and adherence to anti-HER2 therapy containing regimens, and improve understanding of the reasons for discontinuation of this therapy.

This is a retrospective, descriptive, cohort study of approximately 180 female patients diagnosed with HER2-positive metastatic breast cancer in Hungary. Patients diagnosed with, or who progressed to, metastatic disease between 01 September 2009 and 01 September 2010 will be included. All patients will be followed until death, loss to follow-up or the end of the study period (30 September 2012). All data will be collected retrospectively from patient medical records.

Descriptive statistics of the demographic and clinical characteristics of HER2+ metastatic breast cancer patients, including sites of metastases, the time from initial breast cancer diagnosis until diagnosis of metastatic disease, and HER2 testing methodology and status of HER2 will be described. Further, descriptive statistics of the proportion of HER2+ metastatic breast cancer patients who received anti-HER2 therapy, the sequencing of different therapies, and the duration of therapies in the metastatic setting will be analysed. Among the subset of women who receive lapatinib plus capecitabine, descriptive statistics of the timing of initiation of lapatinib plus capecitabine in the metastatic treatment pathway, time to treatment discontinuation and time to progression (TTP) on lapatinib plus capecitabine will be calculated. Further, descriptive statistics of the type and duration anti-HER2 therapies used prior to initiation of lapatinib plus capecitabine and, where relevant, after lapatinib+capecitabine will be performed.

Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients

Discontinuation will be measured from the initiation of lapatinib plus capecitabine to the date of discontinuation of this regimen due to any reason. Patients still responding to lapatinib plus capecitabine at the end of the Follow up Period will be censored at the date of the last follow-up contact.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer	NCT01145404	GastroEsophagea...	Lapatinib Lapatinib plus ...	18 Years -	National Center for Tumor Diseases, Heidelberg
Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)	NCT03080805	HER2 Positive M...	Pyrotinib Plus ... Lapatinib Plus ...	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients	NCT01782651	Neoplasms, Brea...	Lapatinib plus ...	18 Years -	GlaxoSmithKline
Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer	NCT01145404	GastroEsophagea...	Lapatinib Lapatinib plus ...	18 Years -	National Center for Tumor Diseases, Heidelberg
Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer	NCT01145404	GastroEsophagea...	Lapatinib Lapatinib plus ...	18 Years -	National Center for Tumor Diseases, Heidelberg
Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer	NCT01145404	GastroEsophagea...	Lapatinib Lapatinib plus ...	18 Years -	National Center for Tumor Diseases, Heidelberg

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