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

This study is currently recruiting participants. (see Contacts and Locations)
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

August 2, 2012
August 7, 2012
June 2012
June 2014   (final data collection date for primary outcome measure)
Adverse reactions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The occurrence of adverse reactions and the number of cases
Same as current
Complete list of historical versions of study NCT01662128 on ClinicalTrials.gov Archive Site
Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Disease-free survival of 5 years
Same as current
Overall survival,recurrence or death [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Overall survival,recurrence or death of 10 years
Same as current
 
Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer
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

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.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Xeloda
Xeloda as Adjuvant Therapy
Other Name: Xeloda
Experimental: Xeloda
Xeloda
Intervention: Drug: Xeloda
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2022
June 2014   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
China
 
NCT01662128
xeloda
Yes
Zhang jin, Tianjin Medical University
Tianjin Medical University
Not Provided
Study Chair: Jin Zhang, Professor Tianjin cancer hospital
Tianjin Medical University
August 2012

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