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

This study is currently recruiting participants.

Verified August 2012 by Tianjin Medical University

Sponsor:

Information provided by (Responsible Party):

Zhang jin, Tianjin Medical University

ClinicalTrials.gov Identifier:

NCT01662128

First received: August 2, 2012

Last updated: August 7, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 2, 2012

Last Updated Date

August 7, 2012

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse reactions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

The occurrence of adverse reactions and the number of cases

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01662128 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Disease-free survival of 5 years

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Overall survival,recurrence or death [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Overall survival,recurrence or death of 10 years

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Xeloda

Xeloda as Adjuvant Therapy

Other Name: Xeloda

Study Arm (s)

Experimental: Xeloda

Xeloda

Intervention: Drug: Xeloda

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

June 2022

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Karnofsky ≥ 70
Provision of informed consent
Pathological confirmation of breast cancer and exclusion of other metastases.
Pathological confirmation of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis
The patients have finished the chemotherapy of Anthracycline and/or Taxane.And it's no more than 28 days from accepting the last chemotherapy.
Laboratory criteria:

PLT ≥ 100*109/L WBC ≥ 4000/mm3 HGB ≥ 10g/dl GOT,GPT,ALP ≤ 2*ULN TBIL,DBIL,CCr ≤ 1.5*ULN

Exclusion Criteria:

Pregnant or lactation woman
Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ
Accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine therapy
History of organ transplantation
With mental disease
With severe infection or active gastrointestinal ulcers
With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
With heart disease
Experimental drug allergy

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01662128

Other Study ID Numbers ^ICMJE

xeloda

Has Data Monitoring Committee

Yes

Responsible Party

Zhang jin, Tianjin Medical University

Study Sponsor ^ICMJE

Tianjin Medical University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Jin Zhang, Professor

Tianjin cancer hospital

Information Provided By

Tianjin Medical University

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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