Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Immune System Diseases

Breast Neoplasms

Hypersensitivity

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Gemcitabine

Taxane

Antimetabolites

gemcitabine, carboplatin

Soo-Chin Lee, MD

Tumors are heterogeneous with varying response to chemotherapeutic agents. We hypothesize that tumors that are sensitive to a particular chemotherapeutic agent have a distinctive tumor protein profile compared to those that are resistant. We further hypothesize that since tumor is continuously perfused by serum, serum protein profile can be used as a surrogate marker of tumor protein profile. The primary objective of this study is to identify a serum protein profile that predicts gemcitabine/carboplatin sensitivity or resistance in breast cancer patients with prior exposure to anthracyclines and taxanes. Secondary objectives are to establish the serum protein profile of breast cancer patients who have had prior exposure to anthracyclines and taxanes, and to study the pharmacogenetics of gemcitabine toxicity by correlating germline genotype of transporters and drug metabolizing enzymes with plasma and intracellular gemcitabine pharmacokinetics.

Metastatic breast cancer patients previously treated with anthracyclines and taxanes will be treated with gemcitabine and carboplatin every 3 weeks. Serial plasma samples will be collected for proteomics profiling with SELDI-MS that will be correlated with tumor response to identify biomarkers that may predict for chemotherapy sensitivity.

Serum Proteomics to Predict Gemcitabine Sensitivity in Breast Cancer

Serum Protein Profiling as a Predictor of Gemcitabine Sensitivity in Breast Cancer With Prior Exposure to Anthracyclines and Taxanes

National University Hospital, Singapore

Symptoms and General Pathology

Recurrence

Capecitabine

Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14

Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8

Gemcitabine，Capecitabine

Gemcitabine, Carboplatin

Zhongsheng Tong, Master

Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or metastatic breast cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer

A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer

Tianjin Medical University Cancer Institute and Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

surgery

Patricia Poon, Dr

Che Mun Poon, Dr

Chun Key Law, Dr

Roger Ngan, Dr

Chung Kong Kwan, Dr

Cheuk Kin Lo, Dr

Johnny Chan, Dr

TK Au Yong, Dr

Ting Lok Kwan, Dr

Stella Cheung, Dr

Timothy Yip

Siu Kie Au, Dr

To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis

Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small-cell Lung Cancer Before Surgery

Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small Cell Lung Cancer Before Surgery

Eli Lilly and Company

Hospital Authority, Hong Kong

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Serum Proteomics to Predict Gemcitabine Sensitivity in Breast Cancer	NCT00212069	Metastatic Brea...	gemcitabine, ca...	18 Years -	National University Hospital, Singapore
Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer	NCT02207335	Metastatic Brea...	Gemcitabine，Cap... Gemcitabine, Ca...	18 Years - 70 Years	Tianjin Medical University Cancer Institute and Hospital
Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small-cell Lung Cancer Before Surgery	NCT00563160	Lung Neoplasms	gemcitabine, ca... surgery	18 Years - 75 Years	Hospital Authority, Hong Kong

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