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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Xeloda

• Registration Number: NCT01662128
• Lead Sponsor: Tianjin Medical University

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.

Study Timeline

• Study Start: 2012-06
• Status Verified: 2012-08
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-07
• Last Update Submitted: 2012-08-07
• Study First Posted: 2012-08-10
• Last Update Posted: 2012-08-10
• Primary Completion: 2014-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Xeloda	Xeloda	Xeloda

Primary Outcome Measures

Name	Time	Method
Adverse reactions	6 months	The occurrence of adverse reactions and the number of cases

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	5 years	Disease-free survival of 5 years

Trial Locations

Locations (1)

Tianjin Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China