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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01662128
• Other study ID #: xeloda
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 2, 2012
• Last updated: August 7, 2012
• Start date: June 2012
• Est. completion date: June 2022

Study information

• Verified date: August 2012
• Source: Tianjin Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 2022
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Xeloda
Xeloda as Adjuvant Therapy

Locations

Country	Name	City	State
China	Tianjin Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival,recurrence or death	Overall survival,recurrence or death of 10 years	10 years	Yes
Primary	Adverse reactions	The occurrence of adverse reactions and the number of cases	6 months	Yes
Secondary	Disease-free survival	Disease-free survival of 5 years	5 years	Yes