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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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Xeloda
 Phase 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tianjin Medical University:

Primary Outcome Measures:
  • Adverse reactions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The occurrence of adverse reactions and the number of cases


Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Disease-free survival of 5 years


Other Outcome Measures:
  • Overall survival,recurrence or death [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Overall survival,recurrence or death of 10 years


Estimated Enrollment: 600
Study Start Date: June 2012
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xeloda
Xeloda
 Drug: Xeloda
Xeloda as Adjuvant Therapy
Other Name: Xeloda

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Karnofsky ≥ 70
  2. Provision of informed consent
  3. Pathological confirmation of breast cancer and exclusion of other metastases.
  4. Pathological confirmation of triple negative or Her-2 positive or with more than 4 axillary lymph node metastasis
  5. The patients have finished the chemotherapy of Anthracycline and/or Taxane.And it's no more than 28 days from accepting the last chemotherapy.
  6. 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:

  1. Pregnant or lactation woman
  2. Bilateral breast cancer, inflammatory breast cancer or carcinoma in situ
  3. Accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine therapy
  4. History of organ transplantation
  5. With mental disease
  6. With severe infection or active gastrointestinal ulcers
  7. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
  8. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)
  9. With heart disease
  10. Experimental drug allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662128

Locations
China, Tianjin
Tianjin Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: ZHANG SHENG, DOCTOR     86-022-23340123 ext 2901        
Contact: ZHANG SHENG, DORTOR     86-022-23340123 ext 2901        
Principal Investigator: ZHANG JIN, PROFESSOR            
Sponsors and Collaborators
Tianjin Medical University
Investigators
Study Chair: Jin Zhang, Professor Tianjin cancer hospital
  More Information

No publications provided

Responsible Party: Zhang jin, Professor, Tianjin Medical University
ClinicalTrials.gov Identifier: NCT01662128     History of Changes
Other Study ID Numbers: xeloda
Study First Received: August 2, 2012
Last Updated: August 7, 2012
Health Authority: China: Ministry of Health

Keywords provided by Tianjin Medical University:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Capecitabine
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013