Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Anti-Infective Agents

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Fluorouracil

Capecitabine

Cyclophosphamide

Methotrexate

Epirubicin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Anti-Bacterial Agents

Antibiotics, Antitubercular

Folinic Acid

Folate

Vitamin B9

6 cycles of weekly nab-Paclitaxel 100 mg/m2 on days 1, 8, 15 q22 with a week of rest every 6 weeks in combination with capecitabine 2000 mg/m2, days 1 - 14 orally, divided into 2 daily doses every 3 weeks for 6 cycles

4 cycles of chemotherapy with epirubicin plus cyclophosphamide (EC) on day 1 q22

Epirubicin, Cyclophosphamide

6 cycles CMF on days 1 and 8 q29 Cyclophosphamide (500mg/qm), Methotrexate (40 mg/qm), 5 FU (600mg/qm)

Cyclophosphamide, Methotrexate, 5 FU

6 cycles of weekly nab-paclitaxel 100 mg/m2 on days 1, 8, 15 q22 with a week of rest every 6 weeks in combination with capecitabine 2000 mg/m2, days 1 - 14 orally, divided into 2 daily doses every 3 weeks for 6 cycles

Capecitabine, Nab-Paclitaxel

Gunter von Minckwitz, Prof.

Although approximately 50% of new diagnosis breast cancers are in patients above the age of 65, elderly people remain substantially under-represented in clinical trials, and therefore are under-treated. A recent trial of the CALBG in patient's ≥ 65 years with medium risk of breast cancer demonstrated an improved disease-free and overall survival for those treated with AC or CMF compared to those treated with capecitabine alone.

The primary aim of the ICE II trial is to determine the compliance and toxicity of epirubicin plus cyclophosphamide (EC) or CMF versus nab-paclitaxel plus capecitabine as adjuvant therapy in non frail elderly patients.

Primary Objective:

Phase II:

To determine the compliance and safety of epirubicin plus cyclophosphamide or CMF (EC/CMF) and nab-paclitaxel in combination with capecitabine (PX).

Secondary Objective(s):

1. To compare the disease-free survival (DFS) and distant disease free survival (DDFS) with epirubicin plus cyclophosphamide or CMF (EC/CMF) vs. nab-paclitaxel in combination with capecitabine (PX).
2. To compare the overall survival (OS) with epirubicin plus cyclophosphamide or CMF (EC/CMF) vs nab-paclitaxel in combination with capecitabine (PX).
3. To analyze the efficacy of treatments in subgroups according to clinical stratification factors.
4. To determine prognostic factors on tumor tissue collected from primary surgery and to correlate them with study treatment effect.
5. To compare the geriatric assessments scores (Charlson, VES-13, IADL, G8) at baseline and end of therapy.

Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast

An Investigational Randomized Study on Epirubicin Plus Cyclophospamide (EC) or Cyclophosphamide Plus Methotrexat Plus 5-fluorouracil (CMF) Versus Nab-paclitaxel Plus Capecitabine as Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast

German Breast Group

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Female, non-smoker, non-small cell lung cancer

Female, non-smokers, no lung cancer or other types of cancers' healthy population

Chen Kexin, M.D., Ph.D

To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin Population.

Eligibility criteria:

* nonsmoker
* female
* age between 35 and 80
* no other types of tumors history
* frequency-matched cases and controls on gender and age

Outcome measures:

* OR(odds ratio)
* RR(risk ratio)
* CI(confidence interval)
* SAS software

Peripheral blood sample (10 ml) was collected from each study subject. Buffy coats were isolated and frozen for DNA extraction.

GWAS Research of Lung Cancer in Tianjin

GWAS Research of Lung Cancer by Department of Epidemiology and Biostatistics in Tianjin Medical University Cancer Institute and Hospital

A GWAS reported a novel association between the TP63 locus and risk of lung adenocarcinoma; however, this association did not achieve genome-wide significance among never-smoking males or females. We genotyped the TP63 SNPs reported by the previous GWAS (rs10937405 and rs4488809) in 500 never-smoking female lung cancer cases and 500 never-smoking female controls from China. Genetic variation in rs10937405 was associated with lung adenocarcinoma. Our findings provide strong evidence that genetic variation in TP63 is associated with risk of lung adenocarcinoma among non-smoking females.

Tianjin Medical University Cancer Institute and Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast	NCT01204437	Breast Cancer	Epirubicin, Cyc... Cyclophosphamid... Capecitabine, N...	65 Years -	German Breast Group
GWAS Research of Lung Cancer in Tianjin	NCT01255059	Non-small Cell ... Primary Carcino...		35 Years - 80 Years	Tianjin Medical University Cancer Institute and Hospital
Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast	NCT01204437	Breast Cancer	Epirubicin, Cyc... Cyclophosphamid... Capecitabine, N...	65 Years -	German Breast Group
GWAS Research of Lung Cancer in Tianjin	NCT01255059	Non-small Cell ... Primary Carcino...		35 Years - 80 Years	Tianjin Medical University Cancer Institute and Hospital

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