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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


Phase 2/Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Adverse reactions

Outcome Description:

The occurrence of adverse reactions and the number of cases

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Jin Zhang, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Tianjin cancer hospital

Authority:

China: Ministry of Health

Study ID:

xeloda

NCT ID:

NCT01662128

Start Date:

June 2012

Completion Date:

June 2022

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

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