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Spots Global Cancer Trial Database for Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer

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Trial Identification

Brief Title: Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer

Official Title: Randomized Controlled Trials of Efficacy and Safety With Xeloda as Sequential Adjuvant Therapy After Chemotherapy of Anthracycline and/or Taxane in Breast Cancer of Triple Negative or HER-2 Positive or Axillary Lymph Node Metastasis ≥4

Study ID: NCT01662128

Conditions

Breast Cancer

Interventions

Xeloda

Study Description

Brief Summary: Select 600 cases of women with breast cancer of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And the control group will not receive any adjuvant therapy.Finally the investigators will assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using medications.

Detailed Description: The investigators will select 600 cases of women with breast cancer of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis. All the patients were accepted the chemotherapy of Anthracycline and/or Taxane. Divide them into two groups randomly. Then the experimental group will be treated with Xeloda(1000mg/m2,orally,2 times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as Sequential Adjuvant Therapy. And the control group will not receive any adjuvant therapy.Finally the investigators will assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using medications.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Tianjin Cancer Hospital, Tianjin, Tianjin, China

Contact Details

Name: Jin Zhang, Professor

Affiliation: Tianjin Cancer Hospital

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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