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

NCT ID: NCT01662128

Last Updated: 2012-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2022-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Xeloda

Xeloda

Group Type: EXPERIMENTAL

Xeloda

Intervention Type: DRUG

Xeloda as Adjuvant Therapy

Interventions

Xeloda

Xeloda as Adjuvant Therapy

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhang jin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Zhang, Professor

Role: STUDY_CHAIR

Tianjin Cancer Hospital

Locations

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

ZHANG SHENG, DOCTOR

Role: primary

86-022-23340123 ext. 2901

ZHANG SHENG, DORTOR

Role: backup

86-022-23340123 ext. 2901

Other Identifiers

xeloda

Identifier Type: -

Identifier Source: org_study_id