Efficacy and Safety Of Xeloda as Sequential Adjuvant Therapy After Chemotherapy in Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast Cancer
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Xeloda
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Female
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
Location
Tianjin Cancer Hospital
Tianjin, Tianjin, China
Status: Recruiting
Contact: ZHANG SHENG, DOCTOR - 86-022-23340123
Start Date
June 2012
Completion Date
June 2022
Sponsors
Tianjin Medical University
Source
Tianjin Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page